Some results obtained from in vitro quality evaluation of leading brands of ciprofloxacin tablets marketed in Mongolia
- VernacularTitle:Монгол улсын зах зээл дэх ципрофлоксацин шахмал эмийн in vitro орчинд хийсэн чанарын зарим үр дүнгээс
- Author:
Azjargal G
1
,
2
;
Anudari T
2
;
Tsetsegmaa S
1
;
Gereltuya D
1
Author Information
1. School of Pharmacy, Mongolian National University of Medical Sciences
2. Mongolian University of Pharmaceutical Sciences
- Publication Type:Journal Article
- Keywords:
Quality control;
Leading brands;
Ciprofloxacin hydrochloride;
Validation;
pharmacopoeia specifications
- From:
Mongolian Pharmacy and Pharmacology
2018;13(2):21-26
- CountryMongolia
- Language:Mongolian
-
Abstract:
Introduction:Ciprofloxacin is a broad-spectrum antibiotic that acts against a number of
bacterial infections. The study was carried out to examine the in vitro quality control tests for five
leading brands of ciprofloxacin hydrochloride 500 mg tablet formulation, registered in Mongolia. The
quality control parameters of five different brands of ciprofloxacin hydrochloride 500 mg tablets were
determined weight variation, friability, hardness, and disintegration, dissolution and assay tests. In
addition, 0 and first order kinetic models were applied for each sample.
Method:All the tablets were evaluated for conformity with British Pharmacopoeia (BP) and
Mongolian Pharmacopoeia-National Formulary (MP-NF) standards.
Results:Among five brands of tablets Brand C had lower mean weight variation of 0.8% and
Brand A had highest mean weight variation of 3.42%. For friability test Brand B had the lowest mean
friability (0.57) and Brand A had highest mean friability (1.51). The percentages of the drug content
of five brands of ciprofloxacin tablet were obtained in the following sequence: Brand E (98.4 %) <
Brand C (100.3%) < Brand D (115.1%) < Brand A (138.5%) < Brand B (183.8%). E and C brands met
the BP and MP-NF specifications for assay
Conclusion:The present study revealed that Brand A, B and D the leading brands of this
tablet not met the quality control parameters as per pharmacopoeia specifications expect dissolution
test for some brands (Brand A, Brand B).
- Full text:MPPJ-2018-13(2)-21-26.pdf
