A Karthik, G Subramanian, C Mallikarjuna Rao, Bhat Krishnamurthy, A Ranjithkumar, P Musmade, M Surulivelrajan, K Karthikeyan, N Udupa
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal, India.
Pak J Pharm Sci. 2008 Oct;21(4):421-5.
A simple, fast, and precise reverse phase, isocratic HPLC method was developed for the separation and quantification of pioglitazone and glimepiride in bulk drug and pharmaceutical dosage form. The quantification was carried out using Inertsil ODS (250 +/- 4.6 mm, 5 micro) column and mobile phase comprised of acetonitrile and ammonium acetate (pH 4.5; 20mM) in proportion of 60:40 (v/v). The flow rate was 1.0 ml/min and the effluent was monitored at 230 nm. The retention time of pioglitazone and glimepiride were 7.0+/-0.1 and 10.2+/-0.1 min respectively. The method was validated in terms of linearity, precision, accuracy, and specificity, limit of detection and limit of quantitation. Linearity of pioglitazone and glimepiride were in the range of 2.0 to 200.0 microg/ ml and 0.5-50microg/ ml respectively. The percentage recoveries of both the drugs were 99.85% and 102.06% for pioglitazone and glimepiride respectively from the tablet formulation. The proposed method is suitable for simultaneous determination of pioglitazone and glimepiride in pharmaceutical dosage form and bulk drug.
建立了一种简单、快速、准确的反相等度高效液相色谱法，用于原料药和药物制剂中吡格列酮和格列美脲的分离与定量。定量分析采用Inertsil ODS柱（250±4.6 mm，5μm），流动相由乙腈和醋酸铵（pH 4.5；20 mM）按60:40（v/v）比例组成。流速为1.0 ml/min，在230 nm波长处监测流出物。吡格列酮和格列美脲的保留时间分别为7.0±0.1和10.2±0.1分钟。该方法在线性、精密度、准确度、特异性、检测限和定量限方面进行了验证。吡格列酮和格列美脲的线性范围分别为2.0至200.0μg/ml和0.5 - 50μg/ml。两种药物从片剂制剂中的回收率分别为吡格列酮99.85%和格列美脲102.06%。所提出的方法适用于药物制剂和原料药中吡格列酮和格列美脲的同时测定。
