Simultaneous Determination of Gliquidone, Fexofenadine, Buclizine, and Levocetirizine in Dosage Formulation and Human Serum by RP-HPLC

Abstract

In the present paper, a simultaneous method has been developed and validated for estimation of gliquidone in the presence of H(1)-receptor antagonists (fexofenadine hydrochloride, buclizine hydrochloride, and levocetirizine dihydrochloride) using reversed-phase high-performance liquid chromatographic technique. A good chromatographic separation between these drugs was achieved using a mobile phase containing methanol-water (80:20 v/v) at pH 3.5 with a flow rate of 1.0 mL/min; and detection was performed at 230 nm with a UV detector. Validation of the method was performed in terms of linearity, accuracy, precision, and limit of detection and quantification. The linearity of the calibration curves for gliquidone, fexofenadine hydrochloride, buclizine hydrochloride, and levocetirizine dihydrochloride were found to be 0.338-50 microg/mL (r = 0.9964), 5-50 microg/mL (r = 0.9956), 0.325-50 microg/mL (r = 0.9967), and 0.553-50 microg/mL (r = 0.9950), respectively. There was no significant difference between the amount of drug spiked in serum and the amount recovered, and serum did not interfere in simultaneous estimation. Thus, the proposed method is suitable for the simultaneous analysis of active ingredients in tablet dosage forms and human serum.