TITLE:
Quality and Pharmaceutical Equivalence Determinations of Commercially Available Amlodipine Besylate Immediate Release Tablets
AUTHORS:
Farhana Afroz, Suriya Sharmin, Satyajit Roy Rony, Fatema Moni, Md. Hossain Sohrab
KEYWORDS:
Assay, Disintegration, Dissolution, Friability, Pharmacopoeia
JOURNAL NAME:
Pharmacology & Pharmacy,
Vol.13 No.5,
May
26,
2022
ABSTRACT: Counterfeit and substandard drugs possess serious health
risks. Regular
quality screening is very important to ensure the standard and efficacy of pharmaceutical products. The
study aimed to compare the quality of amlodipine besylate tablets available in the Bangladesh drug market and examine their physical and
pharmaceutical equivalence. The various physico-chemical parameters such as diameter,
shape, size, weight variation, thickness, hardness, loss on drying (LOD), friability,
disintegration, dissolution, and assay
have been determined according to the methods mentioned in the United States Pharmacopoeia
(USP) and British Pharmacopoeia (BP). Four brands of amlodipine besylate were purchased from different
local retail stores and coded as ALT1, AMT2, AMT3,
and AST4 on the basis of their market share. All four brands met official
USP specifications. Pharmaceutical equivalence was determined from the dissolution
profile which gives acceptable difference (f1)
and similarity (f2) factor
values for all the brands compared with the benchmark brand for its highest market
share. All the brands also met the USP criteria for assay of not less than 90.0%
and not more than 110.0% of the labeled amount of amlodipine (C20H25N2O5Cl).