Kumari Karra Vijaya, Rao Pilli Nageswara, Kumar Inamadugu Jaswanth, Seshagiri Rao J V L N
University College of Pharmaceutical Sciences, Jawaharlal Nehru Technological University, Kukatpally, Hyderabad-500085, India.
Analytical and Environmental Chemistry Division, Department of Chemistry, Sri Venkateswara University, Tirupati-517502, India.
J Pharm Anal. 2012 Jun;2(3):167-173. doi: 10.1016/j.jpha.2012.01.002. Epub 2012 Jan 28.
A simple and rapid liquid chromatography-tandem mass spectrometric (LC-MS/MS) assay method has been developed and fully validated for simultaneous quantification of pioglitazone and candesartan in human plasma. Irbesartan was used as an internal standard. The analytes were extracted from human plasma samples by solid-phase extraction technique using a Strata-X 33 μm polymeric sorbent. The reconstituted samples were chromatographed on a column by using a 80:20 (v/v) mixture of acetonitrile and 0.1% formic acid as the mobile phase at a flow rate of 0.8 mL/min. The calibration curves obtained were linear (≥0.99) over the concentration range of 15-3000 ng/mL for pioglitazone and 5-608 ng/mL for candesartan. The results of the intra- and inter-day precision and accuracy studies were well within the acceptable limits. A run time of 2.7 min for each sample made it possible to analyze more than 300 plasma samples per day. The proposed method was found to be applicable to clinical studies.
已开发并完全验证了一种简单快速的液相色谱 - 串联质谱（LC-MS/MS）测定方法，用于同时定量人血浆中的吡格列酮和坎地沙坦。厄贝沙坦用作内标。使用Strata-X 33μm聚合物吸附剂通过固相萃取技术从人血浆样品中提取分析物。将重构后的样品在柱上进行色谱分析，使用乙腈和0.1%甲酸的80:20（v/v）混合物作为流动相，流速为0.8 mL/min。获得的校准曲线在吡格列酮浓度范围为15 - 3000 ng/mL和坎地沙坦浓度范围为5 - 608 ng/mL内呈线性（≥0.99）。日内和日间精密度及准确度研究结果均在可接受范围内。每个样品的运行时间为2.7分钟，使得每天能够分析300多个血浆样品。所提出的方法被发现适用于临床研究。
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