Naveed Safila, Dilshad Huma, Nafees Maheen, Shinwari Muhammad Ibrar, Usmanghani Khan, Sarwar Ghulam
Faculty of Pharmacy, Jinnah University for Women, Karachi, Pakistan.
Department of Environmental Sciences, Faculty of Basic & Applied Sciences, International Islamic University, H-10, Islamabad, Pakistan.
Pak J Pharm Sci. 2018 Jan;31(1):69-73.
The aim of study is to establish pharmaceutical equivalence of different brands of Metformin tablets available in Karachi, Pakistan. The quality control parameters which are studied are weight variation test, hardness test, thickness, friability, disintegration and dissolution specified by BP/USP (British and United State Pharmacopoeia). Weight variation and hardness value requirement was complied by all brands. Disintegration time for all brands was within range i.e. 15 minutes and also complies with the BP/USP recommendation. All brands showed more than 90% drug release within forty five minutes. The present conclusion suggests that almost all the brands of Metformin that are available in Karachi meet the specification for quality control analysis. Assay performed by HPLC by keeping flow rate of 1.0 ml/min of the mobile phase and the quantitative evaluation at 225 nm was performed. The retention time of Metformin was found to be 2.5min. Method suitability for the quantitative determination of the drugs was proved by validation according to the International Conference on Harmonization (ICH) guidelines.
本研究的目的是确定在巴基斯坦卡拉奇市可获得的不同品牌二甲双胍片剂的药学等效性。所研究的质量控制参数包括英国药典（BP）/美国药典（USP）规定的重量差异检查、硬度测试、厚度、脆碎度、崩解和溶出度。所有品牌均符合重量差异和硬度值要求。所有品牌的崩解时间均在规定范围内，即15分钟，也符合BP/USP的建议。所有品牌在45分钟内的药物释放量均超过90%。目前的结论表明，卡拉奇市可获得的几乎所有品牌的二甲双胍均符合质量控制分析的规范。采用高效液相色谱法（HPLC）进行含量测定，流动相流速为1.0 ml/min，并在225 nm处进行定量评估。发现二甲双胍的保留时间为2.5分钟。根据国际协调会议（ICH）指南进行验证，证明了该方法对药物定量测定的适用性。
