New Validated UV Spectrophotometric Method for the Quantification of Bisoprolol Fumarate in its Pharmaceutical Dosage Form
Satya Narayan Tripathy, Suryakanta Swain, Bikash Ranjan Jena* and Abhisek Sahu
Department of Pharmaceutical Analysis, School of Pharmacy and Life Science, Centurion University of Technology and Management, Jatani, Bhubaneswar, Odisha, India
*Corresponding Author: Bikash Ranjan Jena, Department of Pharmaceutical Analysis, School of Pharmacy and Life Science, Centurion University of Technology and Management, Jatani, Bhubaneswar, Odisha, India.
November 25, 2022; Published: January 04, 2023
The current investigation signifies, a simple, affordable, precise, and accurate UV spectrophotometric method to estimate and validate lumefantrine concentrations in bulk and pharmaceutical formulations. Shimadzu twin beam UV-VIS spectrophotometer operated by UV probe software was used in the study. The resulting absorbance at a maximum wavelength of 268 nm was observed using the solvent 0.1N HCL. Numerous validation metrics, including accuracy, precision, linearity, and optical characteristics, were used to optimise the established method. Within a concentration range of 10-60 µg/mL, the regression co-efficient (R2) value of 0.997 was incorporated to obtain the linearity Graph. Less than 2%, of the results for accuracy and precision studies were executed, which shows increasing accuracy and precision levels. Due to low %RSD values in the recovery exploration, no excipients were included in the formulation of the tablet dosage form. The proposed method's accuracy study was confirmed at (80%, 100%, 120%) three levels, and the outcomes were validated in accordance with ICHQ2R1 guidelines. These findings indicate that the procedure has practical value as a tool for quality control when analysing drugs in their tablet dosage forms in the pharmaceutical industry.
Keywords: Bisoprolol; Validation; Precision; Accuracy; Optical Characteristics
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