Scope of Harmonisation of Pharmacopoeial Liquid Chromatography (LC) Methods for Diazepam and Its Related Substances

Pakistan Journal of Analytical & Environmental Chemistry

卷:16

Ghulam Qadir Shar¹  Wahid Bux Jatoi¹  Pirbhoo Mal Makheja² 

[1] Department of Chemistry, Shah Abdul Latif University, Khairpur, Sindh, Pakistan;

[2] Ghulam Muhammad Mahar Medical College, Sukkur, Sindh, Pakistan;

关键词: Diazepam;    ;    British Pharmacopoeia;    European Pharmacopoeia;    System suitability;    Liquid Chromatography.;   

DOI  :  

来源: DOAJ

【 摘 要 】

Drug analysis is an imperative activity to check the quality of a drug compound. Pharmacopoeial monographs provide important information about the quality of a drug substance. The expectedquality of a medicine during period of use is also explained in such monographs. Analytical tools such as spectroscopic and chromatographic methods have been developed for such investigations.We have analysed the purity of a well known anxiolytic drug; diazepam, by using liquid chromatographic (LC) technique. It was noticed that with Zorbax Eclipse XDB – C8 (4.6 x 150 mm, 5 μm) column and recommended mobile phase comprising acetonitrile - methanol - potassium dihydrogen phosphate (22+34+44 v/v), the desired results obtained were not according the chromatograms provided by European Pharmacopeia (EP), but by using another column (ACE – 5 – C8) (4.6 x 150 mm, 5 μm), an extra peak of diazepam degradant was obtained, which showed that by using appropriate mobile phase containing CH3CN- CH3OH- KH2PO4 (20+32+48 v/v), the better results can be achieved. The mean retention time for diazepam analysis was 2.9minutes.

【 授权许可】

Unknown