Key result
A validated LC-ESI-MS/MS method was developed for the simultaneous quantification of olmesartan and hydrochlorothiazide in human plasma, demonstrating acceptable precision, accuracy, and recovery.
A novel LC-ESI-MS/MS method was successfully developed and validated for the simultaneous quantification of olmesartan and hydrochlorothiazide in human plasma, suitable for pharmacokinetic studies.
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Enables pharmacokinetic studies of olmesartan-hydrochlorothiazide combinations; extends validated bioanalytical options for hypertension research.
This is the first publication on a complete validated bioanalytical method for estimation of olmesartan (OLM) and hydrochlorothiazide (HCTZ) in human K3 EDTA plasma that chromatographically resolves its olmesartan glucuronide. An API 4000 mass spectrometer was employed in this method where olmesartan d4 (OLMD4) and hydrochlorothiazide −13C, d2 (HCTZD2) served as the internal standard. Sample was prepared by solid phase extraction (SPE) technique using a polymer based, MCX cartridges and chromatographic resolution achieved on Synergi MAX RP-18A, (4.6 × 150 mm, 4 μm) column using a mobile phase of 0.2% formic acid solution/acetonitrile (30:70, v/v). Negative mass transitions (m/z) of OLM, HCTZ, OLMD4, and HCTZD2 were detected in multiple reactions monitoring (MRM) mode at 445.5 → 149.3, 296.0 → 269.0, 449.2 → 149.3, and 299.1→270.0, respectively. The linearity was checked over a concentration range of 4.051–2500.912 ng/mL for OLM and 0.506–304.109 ng/mL for HCTZ. Intra- and inter-run precision of OLM and HCTZ assay at four concentration levels were below 3.7% and 4.3%, and accuracy was within ±4.4% and 3.0%, respectively. Mean recoveries for OLM, HCTZ, and internal standards OLMD4 and HCTZD2 were 75.68, 77.60%, and 80.2, 89.1%, respectively. This method has been successfully applied to pharmacokinetic biostudy.
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Kumar et al. (2013) studied this question. LC-ESI-MS/MS method for olmesartan and hydrochlorothiazide quantification was evaluated on Method validation parameters (linearity, precision, accuracy, recovery). A validated LC-ESI-MS/MS method was developed for the simultaneous quantification of olmesartan and hydrochlorothiazide in human plasma, demonstrating acceptable precision, accuracy, and recovery.
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