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

SHAHNAZ USMAN; M. BASSAM ISMAIL SHEHADA; ANAB USMAN; QUAMRUL ISLAM

doi:10.22159/ajpcr.2021.v14i10.42768

Authors

SHAHNAZ USMAN Department of Pharmaceutics, RAK College of Pharmaceutical Sciences, RAKMHSU, Ras Al Khaimah, UAE.
M. BASSAM ISMAIL SHEHADA Department of Pharmaceutics, RAK College of Pharmaceutical Sciences, RAKMHSU, Ras Al Khaimah, UAE.
ANAB USMAN Department of Medicine, Sindh Medical University, Karachi, Pakistan.
QUAMRUL ISLAM Department of Pharmaceutics, RAK College of Pharmaceutical Sciences, RAKMHSU, Ras Al Khaimah, UAE.

DOI:

https://doi.org/10.22159/ajpcr.2021.v14i10.42768

Keywords:

Comparative dissolution behavior, Glimepiride, High-performance liquid chromatography method of analysis, Pharmaceutical quality assessment, Stability study of tablets

Abstract

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.

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