CC BY
43
JOURNAL OF CLINICAL MEDICINE OF KAZAKHSTAN
Озык, Макала / Оригинальная Статья / Original Article DOI: 10.23950/1812-2892-JCMK-00777
Validated stability Spectrophotometry process for estimation vancomycin antibiotic degradation behavior in pharmaceutical kinds
Mohauman Mohammed Majeed Al-Rufaie
Abstract
Objective: To estimate the dissolution behavior of the antibiotic vancomycin hydrochloride in pharmaceutical formulations, a novel, quick as well as innovative stabilization implying spectrophotometric process has been created and certified. Using the spectrophotometric process to calculate the constant acid dissociation (Ka).
Material and methods: The process focused on the observed drug oxidation by a documented excess of Ceric ammonium nitrate in hydrochloride acid solution as well as corresponding identification of unreacted oxidant by combining it with methylene blue respectively. The oxidant reacted correlates to the substance of the compound. As well as wave length absorbance calculation 588 nm. This approach follows Beer-Lambert plot regression showed remarkable concentration range 1-50 ppm associations. It was a coefficient of correlation of 0.9982. Calculated the limits of molar absorptivity 6.9117* 104 (L . mol-1. cm-1) , sandal sensitivity 0.02 ^g. cm-2, identification 0.410 ppm, as well as quantification 0.731 ppm. The method's precision and accuracy was established and checked.
Results: The stoichiometric proportions were analyzed for the aforementioned product. This measured the growing conditions of reaction as well as other analytical variables. The technique has decent repeatability with little than two percent relative standard deviation (RSD percentage).
Conclusion: The impact of the material typically often used in such medications as excipients was examined. The suggested technique have been implemented in pharmaceutical products to assess such drugs. The findings showed that the technique is as reliable and repeatable as the approved technique.
Keywords: validated stability, spectrophotometric, vancomycin, antibiotic, pharmaceutical forms
ДЭР1Л1К ФОРМАЛАРДАГЫ ВАНКОМИЦИН АНТИБИОТИКТЕРШЩ НАШАРЛАУЫН БАГАЛАУГА АРНАЛГАН Т¥РАЦТЫЛЬЩТЬЩ СПЕКТРОФОТОМЕТРИЯЛЬЩ ПРОЦЕС1
М.М Маджид Аль-Руфайе
Химия кафедрасы, Еылым факультету Куфа Университету Наджаф, Ирак
Т¥ЖЫРЫМДАМА
Максаты: Антибиотик ванкомицин гидрохлоридшщ ертндЫщ касиеттерЫ фармацевтикалык курамда багалау Yшiн спектрофотоме-триялык процесстщ катысуымен жаца, жьлдам жэне инновациялык турактандыру процесi курылды жэне сертификатталдь. К;ышкылдыц диссоциациялану турактысын (Ка) есептеу Yшiн спектрофотометриялык процестi колдану.
Материалдар мен тэсiлдер: Бул процесс препараттыц туз кышкылыныц ерiтiндiсiндегi церий-аммоний нитратыныц кужатталган мел-шерден асып кетуiмен, сонымен катар оны метилен кекпен сэйкестендiру аркылы реакцияланбаган оксиданттыц сэйкестендiрiлуiне багыт-
Эсет ететiн тотыктыргыш косылыстыц затымен байланысады. Жуту толкыны узындшын есептеу 588 нм курайды. Бул тэсiл Бер-Лам-берт кестеанщ регрессиясына сэйкес келедi, ол миллионга 1-50 белiктерге шогырланудчц керемет аукымын керсеттi. Бул корреляция коэффициент 0,9982 болды. Молярлык жуту кабшетмщ шегi есептелдi: 6.9117*104 (литр моль-1 см-1), Санделге сэйкес сезiмталдыfы 0,02 мкг. см-2, идентификациясы 0,410 б/млн, ал сандык керсеткiшi 0,741 б/млн. Эдютщ дэлдiгi мен сенiмдiлiгi аныкталды жэне тексерiлдi.
Нэтижелер: Жогарыда аталган енiм Yшiн стехиометриялык пропорциялар талданды. Реакцияныц есу шарттары, сондай-ак баска аналитикалык айнымалылар елшендi. Бул эдю салыстырмалы стандартты ауыткумен екi пайыздан (салыстырмалы стандартты ауыткудыц пайызы) сэйкес лайыкты жацгыртылуга ие.
Корытынды: ^осымша заттар сиякты препараттарда жиi колданылатын материалдыц эсерi зерттелдi. ¥сынылган эдютеме фарма-цевтикалык препараттарга осындай дэрi-дэрмектердi багалау Yшiн енгiзiлген. Нэтижелер керсеткендей, эдю бектлген эдiс секiлдi сенiмдi жэне жацгыртылуга жатады.
Негiзгi сездер: дэлелденген турактылык, спектрофотометрикалык, ванкомицин, антибиотик, дэрiлiк форма
Chemistry Department, Faculty of Science, Kufa University, Najaf, Iraq
© ®
This work is licensed under a Creative Commons Attribution 4.0 International License
Received: 2020-05-14 Accepted: 2020-06-12 UDC: 618.1
J Clin Med Kaz 2020; 4(58):33-40
Corresponding Author: Mohauman Mohammed Majeed AL-Rufaie, Chemistry Department, Faculty of Science, Kufa University, Najaf, Iraq. Tel: 07809086646, Fax: 07809086646. E-mail: [email protected]
СПЕКТРОФОТОМЕТРИЧЕСКИЙ ПРОЦЕСС ПОДТВЕРЖДЕННОЙ СТАБИЛЬНОСТИ ДЛЯ ОЦЕНКИ УХУДШЕНИЯ ХАРАКТЕРИСТИК АНТИБИОТИКОВ ВАНКОМИЦИНА В ЛЕКАРСТВЕННЫХ ФОРМАХ М.М. Маджид Аль-Руфайе
Кафедра химии, Факультет науки, Университет Куфы, Наджаф, Ирак
РЕЗЮМЕ
Цель: Для оценки свойств растворения антибиотика гидрохлорида ванкомицина в фармацевтических составах был создан и сертифицирован новый, быстрый и инновационный процесс стабилизации, подразумевающий спектрофотометрический процесс. Использование спектрофотометрического процесса для расчета постоянной кислотной диссоциации (Ка).
Материалы и методы: Данный процесс фокусировался на наблюдаемом окислении лекарственного средства документированным избытком нитрата церия-аммония в растворе хлористоводородной кислоты, а также на соответствующей идентификации непрореагировав-шего окислителя путем объединения его с метиленовым синим, соответственно. Реагирующий окислитель коррелирует с веществом соединения. Расчет длины волны поглощения составляет 588 нм. Данный подход соответствует регрессии графика Бера-Ламберта, показавшей замечательный диапазон концентрации 1-50 частей на миллион. Это был коэффициент корреляции 0,9982. Рассчитаны пределы молярной абсорбционной способности 6,9117*104 (л. моль-1. см-1), чувствительность по Санделу 0,02 мкг. см-2, идентификация 0,410 ч/млн, а также количественная оценка 0,731 ч/млн. Точность и достоверность метода были установлены и проверены.
Результаты: Стехиометрические пропорции были проанализированы для вышеупомянутого продукта. Измерены условия роста реакции, а также другие аналитические переменные. Методика имеет достойную воспроизводимость с относительным стандартным отклонением менее двух процентов (процент относительного стандартного отклонения).
Заключение: Изучено влияние материала, обычно используемого в таких препаратах, как вспомогательные вещества. Предложенная методика была внедрена в фармацевтические препараты для оценки таких лекарств. Результаты показали, что методика такая же надежная и воспроизводимая, как и утвержденная методика.
Ключевые слова: подтвержденная стабильность, спектрофотометрический, ванкомицин, антибиотик, лекарственная форма
Introduction
Vancomycin (VAN) is an antibiotic glycopeptide obtained from Streptomyces orientalis as well as Nocardia lucida (Figurel).
Figure 1 - Chemical structure of vancomycin HCl
It was first used in the 1950s to combat staphylococcal illnesses and was rapidly confined to the position of replacement medication given the high occurrence of erotogenic effects and ototoxicity [1]. However, the increasing number of Staphylococcus infections as well as Streptococcus, immune to different antibiotics, have led to regeneration of vancomycin. In fact, the majority of particles were clear of fresh preparation as well as showed limited side effect [2]. Nonetheless, if serum concentrations were maintained beneath 40 mg/l and therapeutic drug management (TDM) was required, it was generally assumed that drug toxicity could be prevented, vancomycin is a first edical glycopeptide antibiotic clinic in 1958. Elucidated at the middle of the 70's, is tricyclic as well as the molecular weight was around 1500Da. Vancomycin works toward grampositive coccus as well as bacillus inhibiting the biosynthesis of the mucopeptide membrane, contributing to a stagnation of productivity [3]. In particular, RNA composition is prevented. Vancomycin is immune to proteolytic enzyme activity related to molecular complexity [2,4]. Several techniques for determining vancomycin have been developed, including capillary electrophoresis [5,6], HPLC [7-11]. Given its reduced cost as well as broad variety of applications, the right technique.
Evaluation on conventional HPLC, furthermore, liquid chromatography processes with fluorescence detection [12],
ultraviolet detection [13-15], mass spectrometry detection [16,17] as well as electrochemical detection [18], other chemical methods also utilized for the assay of VAN drug like radioimmunoassay [19], flow injection analysis [20], fluorescence polarization immunoassay [21], polarography [22] additionally few spectrophotometric processes have been for VAN drug determination as pure drug and in different pharmaceutical bands of VAN drug [23-26]. This article outlines spectrophotometry approach for assessing VAN by oxidizing the product analyzed by a documented excessive of Ceric ammonium nitrate in the solution of hydrochloride acid as well as corresponding measurement of unreacted oxidant by interacting with methylene blue simultaneously. Such reagents, which are helpful for estimating the deterioration activity of vancomycin hydrochloride antibiotics in pharmaceutical products because they also developed reliable and fast organic binding products, are easily accessible, easily filtered and are dissolved in ethanol and are therefore deemed to be a green process.
Material and methods
Chemicals, materials as well as specimens, typical bulk specimens of antibiotic vancomycin hydrochloride (purity 100%) were obtained as a donation test from SDI (State Drug as well as Clinical Appliances Organisation) Samara-Iraq. This solution was compelled by disbanding 0.025g of vancomycin in 100ml of deionized water in the volumetric flask solution Ceric ammonium nitrate 0.001M. Evaporating prepared this solution 0. 0177g of ceric ammonium nitrate (Fluke) in a volumetric flask of 100ml distilled water. Chemicals Ltd solution of methyl blue dye (BDH), 1.6x10-3M: this formula was formulated by disintegrating 0.005g in 100ml of deionized water in the volumetric flask, diluting 10ml for the above solution to 100ml in a volumetric flask with distilled water. Hydrochloric acid eluent (BDH) Chemicals Ltd 2M. The remedy was formed by diminishing 16.4 ml of condensed HCl in the volumetric flask into 100ml of distilled water.
Equipment and apparatuses
Spectrophotometric calculations were performed on UV-visible double beam spectrophotometer (UV-1800, Shimadzu Corp., Japan) connected to computer enforced UV probe 2.0 software with an adjusted spectral bandwidth of 2nm and 10mm.
Table 1
Tested pharmaceutical preparation for vancomycin hydrochloride
Company preparation Composition Pharmaceutical
Zermacin Per vial 0.5 g Vancomycin hydrochloride (Arwan pharmaceutical Industries Lebanon S.a.l, jadra, Lebanon)
Vancomicina Per vial 1g Vancomycin hydrochloride Barcelona, spain
Vancolon Per vial 0.5 g Vancomycin hydrochloride julphar, Gulf pharmaceutical Industries, Ras Al Khaimah, (U.A.E.)
Quartz cells have been utilized for analytical system production across the 200-700nm scope. Medicines as well as substances were weighted on electronic analytical weighted equilibrium Susceptible balance (BL 210S from Sartorius, Thermal-cooling of the water bath (Haake, Fe3).
Assay procedure for pharmaceutical preparations
A handful of vancontaining preparations were evaluated as an active ingredient. This is summarized in Table 1, 2 [27].
General procedure and calibration
Suitable aliquots of antibiotic operating standard solutions for vancomycin hydrochloride were inserted into a system for 25ml volumetric flasks with 250ppm. Instead 1ml of HCl 2M as well as 1ml of ceric ammonium nitrate 0.001M were applied to the solutions for 25 minutes. At room temperature 25ml, eventually add 2ml of methyl blue, instead diminish the flasks to the distilled water mark after 5min.
Around 800-200nm, spectra for the solutions were scanned. The absorption of solutions toward distilled water was calculated at 588nm as water blank. The processed a certain way, but it did not contain any substance [28].
Standard solution preparation and calibration graph
To achieve a concentration of 250ppm, stock solution was produced by disintegrating 250mg of VAN in 100ml of deionized water. Significant volumes were collected from the inventory solution to create the calibration as well as weaken in 25ml volumetric flask simultaneously. The absorbance of each specimen was evaluated on a UV visible spectrophotometer at Amax, towards a blank solution. Perform the latter process for three times as well as estimate a median of three absorbance levels. Taking the notes, the calibration curve was charted using the X-axis VAN concentration as well as the subsequent Y-axis absorption (Figure 2).
Figure 2 - Calibration curve of VAN assay
Table 2
Solvent influence on the absorbance
Solvent Absorbance e ,L.mol-1.cm-1
chloroform 0.332 6.8001x 102
ethanol 0.711 3.5290x 104
methanol 0.651 1.1997x 104
dichloromethane 0.221 2.9247x 103
dimethylsulphoxide 0.231 6.9117x 104
acetone 0.432 1.2610x 103
acetonitrile 0.520 1.8017x 102
Dimethyl formamide 0.421 2.8210x 103
Teri butyl alcohol 0.542 1.3401x 104
Dimethyl sulphoxide 0.188 1.6022x 103
Formic acid 0.259 1.2721x 102
2-propanol 0.471 0.9605x 104
Di ethyl ether 0.302 1.2551x 103
Benzene 0.171 0.1027x 101
Water 0.738 6.9117x 104
Determination in pharmaceutical preparations
The pharmaceutical preparations were received in different kinds (vials) from official sources. Reliably measured amounts of compounded vials, vials or equipment were moved to 100ml volumetric flasks for a loan of 250 mg/l of drugs. Otherwise the spectrophotometric technique implemented was carried out on aliquot sections of the consequent specimen solutions [29].
Solvent effect
Table 2 used both polar as well as nonpolar solvents to choose tasteful solvents for drug evaluation. Water is discovered to be an appropriate solvent for Van, producing optimum absorbance with a specified concentration of drugs, while another solvents generated reduced absorption due to improper complex dissociation [30].
Reaction time influence
Ceric ammonium nitrate engagement with drug stemmed in complex creation that stabilized within 25 minutes of stirring. Starting to add blue methylene after 5 minutes (Table 3). Then the flasks watered down to the limit with distilled water then Spectra was digitized for solution at optimum absorption. The established color stayed stable at room temperature for almost one hour. After 3 days both those solutions are given independence [31].
Validation of the proposed method
The approaches generated were evaluated in terms of international guidelines viz., selectivity, specificity, linearity, LOD, LOQ, precision, accuracy, Shandell's sensitivity as well as reliability (Table 4). The accuracy is tested by rehashing every other project at least 6 times whilst the accuracy was evaluated by
Time of oxidant addition min Standing time before dilution, min.
5 10 15 20 30 40 50 60
5 0.490 0.566 0.433 0.661 0.455 0.526 0.582 0.525
10 0.716 0.516 0.510 0.705 0.571 0.629 0.592 0.565
15 0.722 0.522 0.620 0.719 0.611 0.620 0.624 0.620
20 0.726 0.675 0.685 0.662 0.645 0.665 0.661 0.652
25 0.733 0.711 0.689 0.677 0.661 0.623 0.678 0.681
30 0.721 0.701 0.692 0.688 0.645 0.660 0.681 0.684
20
30
40
50
60
Parameter Values of method
Regression equation Y= 0.0477X - 0.1061
Molar absorptivity 6.9117x 104 (L . mol-1. cm-1)
Correlation coefficient 0.9982
limits of Beer's law (linearity) (1 - 50) (^g/ml or ppm)
Sandell's sensitivity 0.02 [ig . cm-2
Slope, 0.0477
Limit of detection 0.410 (ppm)
Limit of quantitation 0.731 (ppm)
Intercept, 0.1061
Intraday Precision RSD* % 0.917
Inter day Precision RSD* % 1.208
Accuracy(% mean recovery)* % 99.450
0.490
0.566
0.433
0.661
0.455
0.526
0.582
0.525
0.716
0.516
0.510
0.705
0.571
0.629
0.592
0.565
0.722
0.522
0.620
0.719
0.611
0.620
0.624
0.620
0.726
0.675
0.685
0.662
0.645
0.665
0.661
0.652
0.733
0.711
0.689
0.677
0.661
0.623
0.678
0.681
0.721
0.701
0.692
0.688
0.645
0.660
0.681
0.684
Experimental limitation qualities from the consistent method of the calibration curve
Parameter
Regression equation
Molar absorptivity
Correlation coefficient
limits of Beer's law (linearity)
Sandell's sensitivity
Slope,
Limit of detection
Limit of quantitation
Intercept,
Intraday Precision RSD*
Inter day Precision RSD*
Accuracy(% mean recovery)*
Values of method
Y= 0.0477X - 0.1061
6.9117x 104 (L . mol-1. cm-1)
0.9982
(1 - 50) (^g/ml or ppm)
0.02 [ig . cm-2
0.0477
0.410 (ppm)
0.731 (ppm)
0.1061
0.917
% 1.208
% 99.450
Where * average of six determinations
bringing established test weight as well as conducting recovery studies. The technique created was also used for pharmaceutical research. The recovery tests carried out produce high accuracy and precision as well as the findings are contrasted to the verified strategies published on these drugs available. The percentage beliefs of RSD, t-test additionally F-test examinations are within the allowed scope of experiments.
Suitable statistical evaluation was carried out to test the degree of repeatability of the methods. For the repeatability analysis, six specimens of tablet formulations were analyzed. Calculation of standard deviation and RSD percentage [32,33].
Results and discussion Absorption spectra
When a purified aqueous solution of VAN 1ml has been combined with 1ml HCl and 1ml ceric ammonium nitrate as well as continues for 25 minutes after the combination has been introduced methyl blue with a volume of 2ml and stays for 5 minutes, an extreme blue produced spontaneously. The maximum absorption was shown at 588 nm (Figure 3) [29].
Figure 3 - (A) the maximum absorption for dye (methyl blue), (B) the maximum absorption for Drug
Optimizing of the controlled conditions
Segmentation of the effects of different factors on the absorption rate of the formulated substances. For conditions as well as all future experiments to be configured.
The selected dye and concentration
Provisional tests were conducted to improve the effective and optimal dye concentration (methyl blue, that can be spectrophotometric ally calculated). The findings indicate that it was found that methyl blue was a helpful reaction agent, 2ml volume from the dye was the best that given the maximum absorption with 1ml drug, 1ml ceric salt and 1ml of acidic solution [31].
Oxidant amount influence
The impact of various volumes ml of 0.001M of ceric ammonium nitrate on methylene blue dye color without Vancomycin has been reported. Figure 5 demonstrates that 1 ml of ceric ammonium nitrate solution was adequate to acquire full staining or methyl blue dye color, that given highly selectivity for the product, which it was suggested in subsequently tests [29].
Figure 5 - Demonstrates that 1ml of ceric salt solution was the prefect volume on the absorbance level
0 0,5 1 1,5 2 2,5 3 3,5
volume of ceric salt solution
Order of addition influence
Separate orders of attachment of reagents were investigated and it was observed that the sequence of introduction of materials by combining drug and acid hydrochloride with ceric ammonium nitrate after 25min methyl blue solution that provided the strongest absorption after 5min and was used in certain ensuing tests [32].
Type of acid utilized influence in determination process
The reaction studied should be carried out in an acidic medium. The impacts of various acid solutions 2M sulfuric
acid, hydrochloric acid, phosphoric acid, nitric acid as well as acetic acid have therefore been researched. It was noticed that hydrochloric acid was used in all ensuing studies as the most appropriate acidic media for optimum absorption. In another parameters, the influence of different volumes of hydrochloric acid 2M on maximal absorbance was examined by adjusting the volume of HCl between 0.5-2.5ml as well as 1ml was the best (Table 5, Figure 6) [31].
I Acid type effect on the absorbance level
Figure 6 - Volume of HCl ( ml ) effect on the absorbance of color product
0 0,5 1 1,5 2 2,5 3
acidic solution volume
Temperature influence
The impact of temperature on methyl blue color strength has been reported. In reality, maximum absorption was achieved when t in the room (25oC), coloring density and stability were detected at low or high temperatures, so room temperature is indicated for subsequent tests (Figure 7) [34].
Figure 7 - Temperature influence on the absorbance of color product
0,8 -i
0,7 -
0,6 -
S 0,5 -
-e o,4 o
-Q 0,3 -<
0,2 -
0,1 -
0 -
0 10 20 30 40 50 60 70 Temperture
Linearity
The calibration curve was developed through calculating the absorption of vancomycin hydrochloride serial dilutions in distilled water as shown in Figure 4. Vancomycin dilutions were primed in the 1-50ppm concentration range, Beer-Lambert law was compiled in the concentration scope being observed. The calibration curve regression equation was Y=0.477X-0.1061 with a correlation coefficient value of 0.9982, as well as the
Figure 4 - Demonstrates that 2ml of methyl blue color was the finest volume
0,9 -|
0,8 -
0,7 -
0J 0,6 -
c 0,5 -
o 0,4 -
-Q < 0,3 -
0,2 -
0,1 -
0 -
0 1 2 3 4 5 _methyl blue volume_
Y-Intercept standard deviation was discovered to be 0.1061 as shown in Table 4. A correlation coefficient (R2) level for the calibration curve with 0.9982 is called linear. The relative standard deviation levels (percentage RSD) of range 2 are deemed acceptable [22], these levels are shown in Table 4.
Repeatability (precision of intra-assay) to examine the level of repeatability of the processes, prefect statistical assessment was carried out. Six specimens of the vials formulations were analyzed for the repeatability test. The standard deviation additionally % RSD was calculated [35].
The reaction stoichiometry
The stoichiometry of the reaction between VAN as well as the oxidant ceric ammonium nitrate was evaluated utilizing Job's method as well as method of the mole ratio; the conclusions drawn that 1:1 drug to oxidant complex created, the unreacted ceric ammonium nitrate reacting with the methyl blue dye and measuring the absorbance at 588 nm. The product established in distilled water was soluble in the acidic medium according to the process studied [30].
Method for pKa estimation
The dependent or evident stabilization constant of the 1:1 (D:R) substance was tested as obeys: two collections of solutions were formulated, the first collection of solutions was designed to include stoichiometric quantities of the phenolic drug (VAN) to the oxidant. The second set was produced with an oxidant reagent fivefold.
Phenolic product (D) association with the oxidant reagent
(R)
D + R ^ DR
proceeds according to the equation:
and K= [DR]/[D][R]; where K= stability constant
If a is the level of dissociation as well as C is the product's molar concentration (M) equal to the phenolic drug concentration, the latter equation may be as obeys:
K= [1-a]C/[aC][ aC] ..................(1)
= (1- a)/ a2C....................(2)
Provided a=Am-As/Am; where Am and As involve an excess and stoichiometric quantity of oxidant reagent, accordingly. The impact of temperature on the stabilization constant was analyzed as well as the findings showed that the stabilization constant levels at room temperature 25°C were greater than that of 45 °C and 5 °C (Table 6), suggesting that
Table 6 Stability constant at different temperature
Temp., Co Am* As* a C (M) ll.mol-
5 0.519 0.401 0.227 2.5x10-4 M 6.03x104
25 0.679 0.548 0.192 8.78 x104
45 0.577 0.372 0.355 2.04x104
Absorbance Acid Type
0.745 HCl
0.642 H3PO4
0.698 HNO3
0.713 H2SO4
0.511 CH3COOH
a highly stable compound was produced 25°C. VAN as well as an appropriate amount reagent 1ml of 2.5*10-4M of and other methyl blue solution with five times the concentration of the principal concentration. Under the rendered experimental circumstances, the stable average of the coloring component in water was 5.61 xi04 l1.mol-1 [36,37].
Average of three determinations Additives influence
Additives studies included talc, acacia, lactose, sucrose, magnesium stearate, starch, glucose, aspartate, polyvinylpirrolidone PVP, mannitol, Vitamin C as well as benzoic acid. There is no impact on the observations, the solution VAN was established in this operation and each of the additives was acquired individually at concentrations ten times higher than VAN by the same method in the Calibration Curve 2ml of 250ppm VAN additionally 2ml. For each form of additives, dilution to the volumetric flask mark 25ml was introduced for this test. The level of interference should be appropriate if the error was not more than ± 2% as predicted No interference was shown in the VAN test protocol in the additives being tested (average of three examinations) (Table 7) [38,39].
Estimations of VAN 20 ppm in the existence of Additives
Assessment of VAN was conducted in pharmaceutical products as well as in combination with the official system
Additives % Error % Recovery
Sucrose +1.370 101.370
Glucose - 0.740 99.260
starch - 1.010 98.990
Glycerin - 1.230 98.770
Aspartate + 1.460 101.460
mannitol - 1.600 98.400
lactose -.1.110 98.890
magnesium stearate + 1.210 101.210
Vitamin C +1.620 101.620
benzoic acid -1.250 98.750
PVP + 1.210 101.210
Talc - 1.310 98.690
Acacia - 1.330 98.670
Pharmaceutical preparations containing VAN Average recovery % average RSD%
Proposed procedure Standard procedure
Pure VAN 99.450 0.917 100.550 1.310
Vancomycin hydrochloride Vial (0.5g) (Lebanon) VAN 99.660 1.030 98.560 1.450
Vancomycin hydrochloride Vial (1g) (Spain)VAN 100.310 0.930 99.170 1.291
Vancomycin hydrochloride Vial(0.5g) (U.A.E)VAN 100.440 1.071 100.290 1.225
Application of the procedure
The processes were used to study the medicine's assay of pharmaceutical preparations. Concerning the examination of affordable formulations, the following Table 8 appears that.
Wherever the three normal determinations, also, the standard strategy was gotten from (2009) British Pharmacopeia. The outcomes were Replicable and the determination procedures of formulations were through examined by the Standard procedure the studied approaches was felicitously utilized to estimate VAN as pure form and in its pharmaceuticals types. The outcomes given were checked statistical comparison by an F-test variance ratio for precision additionally for accuracy by utilizing Student's t-test with the common approach [5]. The outcomes seen that the values of the F-test additionally t-test were (F=1.33, t=0.47) for medicine lower than the fundamental value (F=9.28 , t=2.45), there was no clear distinction between the tested approaches and common approaches (Three estimations average). Ultimately, F-test as well as t-test values (statistical analysis) seem that there is no considerable variation in accuracy between the tested procedure additionally the common BP procedures. [2,40,41].
Conclusion
The experimental spectrophotometric procedure for determining pKa (i.e. acid dissociation constant) of VAN drug was considered to be quick, sensitive, precise, accurate as well as economical. The concentration drug form was defined utilizing absorbance principles, absorptivity values and continuous equation. The process uses readily available and inexpensive solvent for evaluation, therefore the procedure was also cost-effective. For linearity, accuracy, reproducibility, precision, LOQ, LOD and robustness the system was further tested. The approach could therefore be used efficiently for daily analysis.
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How to cite this article: Mohauman Mohammed Majeed Al-Rufaie. Validated stability Spectrophotometric process for estimation vancomycin antibiotic degradation behavior in pharmaceutical kinds. J Clin Med Kaz. 2020; 4(58):33-40
