Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC AND UV SPECTROSCOPY METHOD FOR THE DETERMINATION OF “BISOPROLOL FUMARATE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

Mayuri K. Patil*, Pawan I. Naik and Dewal K. Patil

ABSTRACT

Objective: Objective of the present analytical research work was to develop and validate simple, accurate, precise, and generate inheriting Validation data for Bisoprolol Fumarate used the wavelength of uv spectrophotometer and uv spectrophotometry and Reversed phase-high performance liquid chromatography (RP-HPLC method) for the determination of Bisoprolol fumarate in bulk drug and pharmaceutical dosage form. Methods: Method A (UV Spectrophotometric method): Stock I Standard Sample preparation and Stock II Tab solution Preparation of drugs prepared in methanol. mobile phase Methanol: Water(0.05%OPA)Water, prepared in (65mlMEOH: 35ml WATER v/v). Standard solutions were scanned in the range of 200- 400nm, against 10 ml Methanol and volume make with water solvent system as reference Bisoprolol Fumarate were showed absorbance maxima (lamda max) at 272 nm. Method B (RP-HPLC Method): The RP-HPLC method for bisoprolol fumarate developed by using column (Grace) C18 Column (4.6nm x 250nm). 5um particle size packaging, 3.0 pH.Stationary phase C18 (Grace). Methano: Water (0.05% OPA) (65:35) As mobile phase at flow rate of 0.7 ml/min and detection was carried out at 272nm. Result: Bisoprolol fumarte was found to be linear in concentration for spectroscopic method was found to be 99% the amount of bisoprolol fumarate in pharmaceutical dosage form by RP-HPLC Method was found to be 99.8% both The developed method was validated as per ICH guidelines.

Keywords: The RP-HPLC method for bisoprolol fumarate developed by using column (Grace) C18 Column (4.6nm x 250nm).