Simultaneous determination of ACE inhibitors and dexibuprofen in active pharmaceutical ingredient, formulations and human serum by RP-HPLC.

The contemporary work describes a rapid and cost effective reversed phase High Performance Liquid Chromatography (RP-HPLC) method for the quantification of Captopril, Lisinopril and Dexibuprofen (DXP) simultaneously in dosage formulations, active pharmaceutical ingredients and human serum. The chromatographic system included LC-20A pump, Sil-20A auto sampler and SPD-20A UV/visible detector. The estimation was carried out by using a C18 (5μm, 250 ×4.6 mm) column with mobile phase methanol: water (80:20 v/v, pH 3.0) at 230 nm with a flow rate of 1.0 ml•min. The retention time of Dexibuprofen was 5.4 min while that of Captopril and Lisinopril were found to be 3.2 and 1.8 minutes respectively. There was no considerable variation exists in between the tested drug spiked in serum and the extent recovered, without interference of serum in concurrent approximation. The method developed was found to be precise, selective and validated for precision, linearity, specificity, accuracy, limit of detection and limit of quantitation. There is no such method reported earlier for the determination of ACE Inhibitors and DXP simultaneously. The present study helps in assessing the co-administration of both drugs in treatment and can be employed for quality control analysis and drug-drug interaction studies.