ON THE DETERMINATION OF AMLODIPINE CONTENT IN AMLODIPINE 10 MG TABLET
- VernacularTitle: АМЛОДИПИН 10 мг ШАХМАЛЫН ҮЙЛЧЛЭГЧ БОДИСЫН АГУУЛАМЖИЙГ
- Author:
Б.Даваадулам
1
;
Л.Хүрэлбаатар
;
С.Пүрэвсүрэн3
Author Information
1. ЭМШУИС
- Publication Type:Journal Article
- Keywords:
THE DETERMINATION OF AMLODIPINE CONTENT
- From:
Mongolian Pharmacy and Pharmacology
2012;1(1):9-12
- CountryMongolia
- Language:Mongolian
-
Abstract:
Introduction: Amlodipine is one of the products included in Mongolian Essential Medicine list. Local drug manufacturers don’t produce this product and our country imports this product from several countries. Drug research institute has developed the technology to produce Amlodipine 10 mg tablet on the scientific basis and quality study has to be performed. Goal: The aim of this study was to define suitable conditions of quantitative determination and in vitro bioequivalence study of Amlodipine 10 mg tablet developed by Drug research institute. Materials and Methods: Assay method was developed using British and Russian pharmacopeia [5,7] and international journals [8,9]. High performance liquid chromatography (HPLC) separation was performed using Shimadzu HPLC with UV detection which is analytical column Оctadecylsilane (150x4.6 mm, particle size 5 μm). Separation took place at 40oC, flow rate of mobile phase (buffer-acetonitrile-methanol, 50:15:35) was 1.0 ml/min. Normodipine and Amlodenk used as standard medicine. Results: In the framework of this study HPLC and spectrophotometer method to determine amlodipine content was developed. The amlodipine content was determined by both methods as 0.0108 g and 0.0109 g respectively. Amlodipine dissolution was 110%, Normodipine dissolution was 110%, Amlodenk 109%. Conclusions: Assay method of Amlodipine 10 mg tablet was developed. Quality criteria of the tablet were determined and manufacturer’s pharmacopiea’s monograph for Amlodipine 10 mg tablet was developed. Amlodipine was bioequivalence with standard medicines.
