Simultaneous LC determination of rosuvastatin, lisinopril, captopril, and enalapril in API, pharmaceutical dosage formulations, and human serum

Abstract

A sensitive, economical, and rapid LC method for the quantification of CVD’s rosuvastatin, lisinopril, captopril, and enalapril in bulk drug, pharmaceutical dosage formulations and in human serum has been developed and validated. Chromatographic separation was performed by methanol:water (75:25 v/v) as mobile phase whose pH was adjusted to 3.0 by o-phosphoric acid; flowing at a rate of 1.0 mL min⁻¹ through pre-packed Purospher Star C18 (5 μm, 25 × 0.46 cm) column at ambient temperature. UV detection was performed at isosbestic point 214 nm. The method shows good linearity in the range of 0.5–25 μg mL⁻¹ for rosuvastatin (R ² = 0.998) and 1–50 μg mL⁻¹ for lisinopril, captopril and enalapril (R ² = 0.999). All LOD values were ≤130 and LOQ ≤ 370 ng mL⁻¹ for API and human serum. The % recoveries of all drugs were between 98.07 and 102.51% in dosage formulations and human serum. The ICH guidelines were followed for the validation of method. The method can be employed for pharmacokinetic studies, routine QC analysis of dosage formulations, and laboratory analysis in blood samples of high cholesterol and hypertension patients.