Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLC-MS/MS and its application in bioequivalence studies

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• 作者：Bhupinder Singh^a ; ^{bs_khubber@yahoo.com" class="auth_mail} ; ^{bhupinder_singh@clinsys.com" class="auth_mail} ; Rama S. Lokhandae^b ; Ashish Dwivedi^a ; Sandeep Sharma^a ; Naveen Dubey^a
• 关键词：Candesartan cilexetil ; Hydrochlorothiazide ; UPLC&ndash ; MS/MS ; Bioequivalence ; Candesartan cilexetil-hydrochlorothiazide (ATACAND HCT)
• 刊名：Journal of Pharmaceutical Analysis
• 出版年：April, 2014
• 年：2014
• 卷：4
• 期：2
• 页码：144-152
• 全文大小：1363 K

文摘

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 d₄ and HCT-¹³Cd₂ 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脳4.6 mm, 5 碌m) 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.