DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BISOPROLOL IN BULK MATERIAL AND IN TABLETS
Authors: Prabhakar M , VAMSHI RM, SHIRISHA RN, NEHA B, VENKATESWARA RP, AKIFUL HM, VASUDHA B, NARENDER B*

ABSTRACT
Back ground: Pharmaceutical analysis plays a vital role in the Quality Assurance and Quality control of bulk drugs. Bisoprolol fumarate is the most potent beta1-selective beta- blocker. It has the highest power of selective beta1-activity and by blocking the beta1- adrenergic receptors. Objective: A simple, rapid, accurate and economical first order UV-derivative spectrophotometric method has been developed for estimation of bisoprolol from bulk and pharmaceutical formulation. Method: The ?max of bisoprolol in methanol was found to be 273 nm. The drug follows linearity in the concentration range 10-60 ?g/ml with correlation coefficient value 0.999. Results: The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 95% was found in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 80%, 100% and 120%. The % recovery was found to be in the range 98% - 102%. The low values of % RSD are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The % RSDvalue less than 2 indicate that the method is precise. Ruggedness of the proposed method was studied with the help of two analysts. Conclusion: The above method was a rapid and cost-effective quality control tool for routine analysis of bisoprolol in bulk and in pharmaceutical dosage form. Keywords: Bisoprolol, beta-blocker, first order derivative, UV-Spectrophotometry, methanol, validation
Publication date: 01/06/2023
    https://ijbpas.com/pdf/2023/June/MS_IJBPAS_2023_7214.pdf
Download PDF
https://doi.org/10.31032/IJBPAS/2023/12.6.7214