Singh Bhupinder, Lokhandae Rama S, Dwivedi Ashish, Sharma Sandeep, Dubey Naveen
Jubiliant Clinsys Limited, Noida, New Delhi, India.
Jaipur National University, Jaipur, India.
J Pharm Anal. 2014 Apr;4(2):144-152. doi: 10.1016/j.jpha.2013.05.003. Epub 2013 Jun 19.
A validated ultra-performance liquid chromatography mass spectrometric method (UPLC-MS/MS) was used for the simultaneous quantitation of candesartan (CN) and hydrochlorothiazide (HCT) in human plasma. The analysis was performed on UPLC-MS/MS system using turbo ion spray interface. Negative ions were measured in multiple reaction monitoring (MRM) mode. The analytes were extracted using a liquid-liquid extraction (LLE) method by using 0.1 mL of plasma volume. The lower limit of quantitation for CN and HCT was 1.00 ng/mL whereas the upper limit of quantitation was 499.15 ng/mL and 601.61 ng/mL for CN and HCT respectively. CN d and HCT-Cd were used as the internal standards for CN and HCT respectively. The chromatography was achieved within 2.0 min run time using a C18 Phenomenex, Gemini NX (100 mm×4.6 mm, 5 µm) column with organic mixture:buffer solution (80:20, v/v) at a flow rate of 0.800 mL/min. The method has been successfully applied to establish the bioequivalence of candesartan cilexetil (CNC) and HCT immediate release tablets with reference product in human subjects.
采用经过验证的超高效液相色谱-质谱联用方法（UPLC-MS/MS）同时定量测定人血浆中的坎地沙坦（CN）和氢氯噻嗪（HCT）。分析在配备涡轮离子喷雾接口的UPLC-MS/MS系统上进行。在多反应监测（MRM）模式下测定负离子。采用液-液萃取（LLE）法，取0.1 mL血浆体积萃取分析物。CN和HCT的定量下限均为1.00 ng/mL，而CN和HCT的定量上限分别为499.15 ng/mL和601.61 ng/mL。分别以CN-d和HCT-Cd作为CN和HCT的内标。使用Phenomenex Gemini NX C18柱（100 mm×4.6 mm，5 µm），有机混合物∶缓冲溶液（80∶20，v/v），流速为0.800 mL/min，在2.0分钟的运行时间内完成色谱分析。该方法已成功应用于在人体受试者中建立坎地沙坦酯（CNC）和HCT速释片与参比制剂的生物等效性。
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