RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF BISOPROLOL IN BULK DRUG AND DOSAGE FORM
Keywords:
RP-HPLC, Bisoprolol, Methanol, Validation.Abstract
Several spectrophotometric and HPLC methods have been reported for determination of Bisoprolol in drugs and pharmaceutical dosage forms. Present study focuses on development of a new, sensitive, suitable and robust reversed-phase high performance liquid chromatography method and validated for the determination of Bisoprolol in bulk drug and in tablet formulation.
In RP-HPLC method, Methanol and Water (75:25 % v/v) was used as mobile phase, at a flow rate of 1.0 ml/min, on HPLC system containing UV- detector with Openlab EZchrome software and Kromasil C18, 250 mm X 4.6 mm, 5 µm. The detection was carried out at 258 nm. The method gave suitable retention time i.e. 3.60 min for Bisoprolol.
The results of analysis in the method were validated in terms of Filter study, Solution stability, specificity, Linearity, accuracy, precision (Repeatability and intermediate precision), limit of detection, limit of quantification and robustness.
A simple and precise method was developed for the assay of Bisoprolol in bulk drug and in tablet formulation.