Abstract
A reliable, simple, and robust liquid chromatography-tandem mass spectro-metric (LC-MS/MS) method has been developed and validated that employs solid-phase extraction for the simultaneous estimation of amlodipine and valsartan in human K3EDTA plasma using amlodipine-d4 and valsartan-d9 as internal standards. Chromatographic separation of amlodipine and valsartan was achieved on the Luna C18 (2)100A (150 × 4.6 mm, 5 μm) column using acetonitrile: 5 mM ammonium formate solution (80:20, v/v) as the mobile phase at a flow rate of 0.8 mL/min in isocratic mode. Quantification was achieved using an electrospray ion interface operating in positive mode, under multiple reaction monitoring (MRM) conditions. The assay was found to be linear over the range of 0.302–20.725 ng/mL for amlodipine and 6.062–18060.792 ng/mL for valsartan. The method has shown good reproducibility, as intra- and interday precisions were within 10% and accuracies were within 8% of nominal values for both analytes. The method was successfully applied for the bioequivalence study of amlodipine and valsartan after oral administration of a fixed dose of the combination. Additionally, as required by the current regulatory bodies, incurred sample reanalysis was performed and found to be acceptable.
Highlights
Hypertension is a major cause of cardiovascular mortality worldwide
The single pill combination of amlodipine and valsartan, under the said category, is associated with greater absolute blood pressure reductions and fewer dosedependent adverse effects when compared with the use of an individual drug [3]
The optimization of the source and compound parameters was done by syringe pump infusion of each analyte
Summary
Hypertension is a major cause of cardiovascular mortality worldwide. A complex therapeutic regimen is required in hypertensive patients to control blood pressure, which leads to patient discomfort. Patient compliance can be increased by administering fixeddose combinations of antihypertensive agents which effectively lower blood pressure. The combination of a calcium channel blocker and an angiotensin II receptor (AT1) blocker as a single-pill, fixed-dose treatment is possibly the best therapy for preventing hypertension [1, 2]. The single pill combination of amlodipine and valsartan, under the said category, is associated with greater absolute blood pressure reductions and fewer dosedependent adverse effects when compared with the use of an individual drug [3]. More than 90% of administered amlodipine gets absorbed when taken orally It has a half-life of 35–45 hr due to the high volume of distribution (21 L/kg) and gets excreted by hepatic metabolism [4]. 94–97% is bound to plasma proteins with a half-life of 7–8 h and is excreted in bile [5]
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