RP-LC method for the simultaneous determination of gliquidone, pioglitazone hydrochloride, and atorvastatin in formulations and human serum

Abstract

The objective of this research was to develop and validate a rapid, economical, and sensitive HPLC method for quantitative determination of gliquidone, pioglitazone hydrochloride, and atorvastatin in tablets and serum. Due to drug combination of these formulations, there has been a need for a reliable quantitative method to determine these drugs in commercial samples and human serum. The chromatographic separation was carried out at ambient temperature with a mobile phase consisting of methanol-water (90 + 10, v/v), with pH adjusted to 3.50 with phosphoric acid. The pump was operated at a flow rate of 1 mL/min, and all analytes were detected at 235 nm. The method was linear over the concentration range of 5-50 μg/mL for all the drugs. The LOD of gliquidone, pioglitazone hydrochloride, and atorvastatin was 0.30, 1.30, and 0.57 μg/mL and LOQ was 0.98, 4.28, and 1.90 μg/mL, respectively. The proposed method was successfully applied to the determination of these drugs in commercial tablets and human serum. The established method was validated with respect to specificity, linearity, precision, accuracy, and ruggedness.