Analytical Method Development And ICH-Guided Validation of A RP-HPLC Procedure for Buspirone Estimation in Bulk and Tablets (Research Article)

Author(s): Durgadevi. G, Abirami. R, Jenifer Silpa Rani. J, Siddhartha. N, Suryaprakash. R, Vivin. T

Abstract: Buspirone is a widely prescribed anxiolytic drug which requires reliable analytical techniques to ensure the safety, quality, efficiency and consistency of its pharmaceutical dosage forms. Although various chromatographic methods have been reported, many lack optimal sensitivity, short run time performance or comprehensive validation in accordance with regulatory expectations. So, there’s need for an efficient RP-HPLC method that is rapid, cost-effective, and suitable for routine quality-control applications in both bulk and tablet formulations. The present study aims to develop and validate a robust RP-HPLC method for the quantitative estimation of Buspirone in bulk and pharmaceutical formulations. Buspirone was analyzed under isocratic conditions using Shimadzu C18 column using 0.1 M acetate buffer (pH 5) and acetonitrile (45:55) at 1 ml/min and 25 °C with chromatographic detection at 245 nm. The developed method has achieved a sharp and well resolved Buspirone peak with a retention time of 3.4 minutes achieving rapid analysis. The calibration curve gave excellent linearity from 1 to 5 µg/ml range, with a correlation coefficient of 0.9998 showing its reliability. Sensitivity parameters showed LOD and LOQ values of 6.36 µg/ml and 19.28 µg/ml, respectively. Precision for both intra-day and inter-day analysis showed %RSD values less than 2% and repeatability measurements confirmed consistent peak areas. Validation parameters such as linearity, accuracy, precision, robustness, and sensitivity complied with ICH guidelines confirming the consistency, reliability, efficiency and suitability of method for routine applications such as drug development, routine QC analysis and broader pharmaceutical research. This study offers a practical and economical RP-HPLC method for Buspirone estimation.

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