RESUMO
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.
RESUMO
Introduction: There were 36 medicine manufacturers and only two of them manufactured antibiotic capsules in 2010. In last year number of manufacturing capsule has been increasing. 2574 medicines and active pharmaceutical ingredients were registered in 2011 and 488 of them were antibiotics. Aim: The main aim of this investigation was to define items of imported and manufactured capsules and do comparative analysis of some capsules. Material and methods: Registered medicine list of Mongolia and questionnaire with 22 questions, and capsules of 2 domestic and 3 foreign manufacturers were used for this investigation. Results, conclusion: 10.84% of registered medicines is capsules, of which and 16.33% from India, 7.82% from China, 5.78% from Indonesia, 8.5% from Slovenia, and other countries. 3.4% of registered capsules are manufactured in Mongolia. All medicine manufacturers import hard gelatin capsules from China and use for the manufacturing. 71.4% of domestic manufacturers use technological parameters, 57.1% stability and dissolution, 28.5% chemical properties and interaction with active pharmaceutical ingredients and excepients as the main criteria for the capsule selection used for the manufacturing. 40.0% of capsules used for the manufacturing is 0 size capsule. 72.2% of manufactured capsules are antibiotics. Quality parameters of imported and manufactured Ampicilline capsule were determined in the frame of this investigation. Conclusion: Items of imported and manufactured capsules, selection criteria of capsules used for the manufacturing were determined. Comparative quality analysis of Ampicilline capsule was done and some quality parameters of imported and manufactured Ampicilline capsule were in accordance of MNS 5097:2007. Key words: Ampicillin trihydrate 500 mg, dissolution test