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.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2023/12.6.7214