Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLC-MS/MS and its application in bioequivalence studies
- Author:
Singh Bhupinder
;
Lokhandae S. Rama
;
Dwivedi Ashish
;
Sharma Sandeep
;
Dubey Naveen
- Publication Type:Journal Article
- Keywords:
Candesartan cilexetil;
Hydrochlorothiazide;
UPLC-MS/MS;
Bioequivalence;
Candesartan cilexetil-hydrochlorothiazide (ATACAND HCT)
- From:
Journal of Pharmaceutical Analysis
2014;(2):144-152
- CountryChina
- Language:Chinese
-
Abstract:
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 Pheno-menex, Gemini NX (100 mm ~ 4.6 mm, 5 mm) 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.
