Abstract

A NEW CHROMATOGRAPHIC METHOD DEVELOPED STABILITY INDICATING FOR THE SIMULTANEOUS ESTIMATION OF BISOPROLOL AND HYDROCHLORTHIAZIDE IN PHARMACEUTICAL DOSAGE FORMS

P. Renuka*, M. Ramakrishna and D. J. Mani Babu

ABSTRACT

The proposed study, a new chromatographic method was developed stability indicating for the simultaneous estimation of bisoprolol and hydrochlorothiazide in pharmaceutical dosage form. The present method was simple, sensitive, rapid, linear, precise and accurate RP-HPLC method for analysis of bisoprolol and hydrochlorothiazide. To optimize mobile phase, various combinations of buffer and organic solvent were used on Zodiac C18 (150 x 4.6 mm, 5μm) column. Then mobile phase containing mixture of phosphate buffer and acetonitrile in the ratio of 80:20 v/v was selected at flow rate 1 ml/min for developing a method and peaks with good shape. The retention time of bisoprolol and hydrochlorothiazide was found to be 2.253 min and 4.425 min respectively. The linearity was obeyed in the range 2.5-75μg/ml and 3-90μg/ml of bisoprolol and hydrochlorothiazide, respectively. The chromatograms of bisoprolol and hydrochlorothiazide of standards and sample were identical with nearly same retention times, which indicate the proposed method was specific. The limit of detection and limit of quantitation was found to be 2μg/ml and 6μg/ml (bisoprolol), 0.9μg/ml and 1.8 μg/ml (hydrochlorothiazide) respectively, which indicates the sensitivity of the method. The high percentage of recovery indicates the proposed method is highly accurate. No interfering peaks were found in the chromatogram indicating that excipients used in injection formulation didn’t interfere with the estimation of the drugs by the proposed RP-HPLC method.

Keywords: Estimation, RP-HPLC, Bisoprolol, Hydrochlorothiazide, Assay.