scholarly journals PHARMACEUTICAL QUALITY ASSESSMENT OF GLIMEPIRIDE TABLETS – COMPARISON OF BRANDS AND NEWLY FORMULATED TABLETS WITH INNOVATOR

2021 ◽  
pp. 63-67
Author(s):  
SHAHNAZ USMAN ◽  
M. BASSAM ISMAIL SHEHADA ◽  
ANAB USMAN ◽  
QUAMRUL ISLAM
Keyword(s):  
Drug Release ◽  
High Performance ◽  
P Value ◽  
Drug Release Profile ◽  
Chromatography Method ◽  
Drug Products ◽  
Accuracy And Precision ◽  
Weibull Models ◽  
Kinetic Assessment ◽  
Liquid Chromatography Method

Objective: The main objective of the study was to assess the quality attribute of generic brands and newly formulated tablet of glimepiride and compare their drug release profile with innovator brand. Methods: Different brands were purchased from different markets of UAE. The validated high-performance liquid chromatography method was used to assess the quantitative analysis of glimepiride. The linearity of curve (r² = 0.9999) indicated the accuracy and precision of the analytical method. Comparative dissolution of newly formulated and generic tablets was carried out using USP dissolution apparatus II. Study was accomplished in phosphate buffer (pH = 7.8), the paddle speed was adjusted at 75 rpm. F1 and F2 factor among the brands and kinetic assessment were done to obtain the order of release. Results: Dissolution profiles of formulated tablets were almost same as that of innovator, 91.53 and 94.9, respectively, in 15 min. The statistical value between the different brands (F = 3.698) indicated that there were some differences among the few groups of tablets and p-value (0.002154) indicated that it supported H1 hypothesis. First-order and Weibull models described the drug release with r2 value of 0.9981–0.927210 and 0.9992– 0.9835, respectively. Stability of optimized formulated batch was also examined. Conclusion: It was concluded that the formulated tablets are stable and pharmaceutically as good as the innovators; however, all the selected brands could not be used interchangeably in the clinical practice. It was also concluded that the scrutiny and screening of the drug products, available in the markets, can help to build a better health-care setup.

scholarly journals Extractive Spectrophotometric Methods for Determination of Zolmitriptan in Tablets

2007 ◽  
Vol 90 (5) ◽  
pp. 1237-1241 ◽  
Author(s):  
Zeynep Aydogmus ◽  
Ipek Inanli
Keyword(s):  
High Performance ◽  
Correlation Coefficients ◽  
Bromothymol Blue ◽  
Chromatography Method ◽  
Statistical Comparison ◽  
Spectrophotometric Methods ◽  
Accuracy And Precision ◽  
Liquid Chromatography Method ◽  
Comparison Of The Results

Abstract Two simple and sensitive extractive spectrophotometric methods have been developed for determination of zolmitriptan (ZTP) in tablets. These methods are based on the formation of yellow ion-pair complexes between ZTP and tropaeolin OO (TPOO) and bromothymol blue (BTB) in citratephosphate buffer of pH 4.0 and 6.0, respectively. The formed complexes were extracted with dichloromethane and measured at 411.5 and 410 nm for TPOO and BTB, respectively. The best conditions of the reactions were studied and optimized. Beer's law was obeyed in the concentration ranges of 220 and 1.517 g/mL with molar absorptivities of 1.42 104 and 1.60 104 L/mol/cm for the TPOO and BTB methods, respectively. Correlation coefficients were 0.9998 and 0.9999 for TPOO and BTB methods, respectively. Limits of detection of the TPOO and BTB methods were 0.341 and 0.344 g/mL, respectively, and the limits of quantitation were 1.034 and 1.051 g/mL, respectively. Sandell's sensitivity and stability constant were also calculated. The proposed methods have been applied successfully for the analysis of the drug in its dosage forms. No interference was observed from excipients present in tablets. Statistical comparison of the results with those obtained by a high-performance liquid chromatography method showed excellent agreement and indicated no significant differences in accuracy and precision.

scholarly journals A modified high performance liquid chromatographic method for simultaneous quantification of skatole and indole in porcine plasma

2012 ◽  
Vol 81 (2) ◽  
pp. 153-158 ◽  
Author(s):  
Carl Brunius ◽  
Galia Zamaratskaia
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
High Selectivity ◽  
High Performance Liquid Chromatographic ◽  
Boar Taint ◽  
Chromatography Method ◽  
Accuracy And Precision ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatography Method ◽  
Liquid Chromatographic

A simplified high-performance liquid chromatography method to measure skatole and indole in porcine plasma without the use of acetonitrile was developed and validated in this study. The mobile phase consisted of water and methanol used in a gradient programme. Fluorescence detection was performed on the supernatant obtained from plasma after protein precipitation with 100% acetone. Limits of quantification were 0.5 ng∙ml-1 for skatole and 1.0 ng∙ml-1 for indole. Accuracy and precision had less than 12% deviation in the linear ranges (0.5–256 ng∙ml-1 and R2 = 0.9999 for skatole, 1.0–256 ng∙ml-1 and R2 = 0.9999 for indole). The correlation between plasma and serum concentrations was strong for skatole (slope = 1.01, R2 = 0.999) and moderate for indole (slope = 0.65, R2 = 0.95). Analysis of skatole in plasma was in good accordance with our previous acetonitrile-based method (slope = 0.91, R2 = 0.988). The proposed method is suited for rapid routine analysis because of its high selectivity, accuracy and precision. Furthermore, it needs only simple sample preparation and the use of methanol instead of acetonitrile in the mobile phase. This method is of practical use to researchers in the field of boar taint.

scholarly journals HPLC Quantification of Cytotoxic Compounds fromAspergillus niger

2017 ◽  
Vol 2017 ◽  
pp. 1-7
Author(s):  
Paula Karina S. Uchoa ◽  
Leandro Bezerra de Lima ◽  
Antonia T. A. Pimenta ◽  
Maria da Conceição F. de Oliveira ◽  
Jair Mafezoli ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Standard Deviation ◽  
High Performance ◽  
Chromatography Method ◽  
Relative Standard ◽  
Validation Parameters ◽  
Cytotoxic Compounds ◽  
Liquid Chromatography Method ◽  
Marine Strain

A high-performance liquid chromatography method was developed and validated for the quantification of the cytotoxic compounds produced by a marine strain ofAspergillus niger. The fungus was grown in malt peptone dextrose (MPD), potato dextrose yeast (PDY), and mannitol peptone yeast (MnPY) media during 7, 14, 21, and 28 days, and the natural products were identified by standard compounds. The validation parameters obtained were selectivity, linearity (coefficient of correlation > 0.99), precision (relative standard deviation below 5%), and accuracy (recovery > 96).

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