Development and Validation of a UV Spectroscopic Method for the Estimation of Gepirone Hydrochloride in Bulk and Tablet Dosage Form in Dissolution Media

Abstract

This work focuses on developing and validating an accurate ultra-violet (UV) spectroscopic approach to quantify gepirone hydrochloride for in vitro dissolution studies in its pure drug and pharmaceutical dosage form. The method was designed to be straightforward, cost-effective, efficient, and suitable for routine analysis and quality control in pharmaceutical laboratories. With 0.1N HCl and phosphate buffer(pH-6.8), the gepirone hydrochloride exhibited λ_max at 233 and 235 nm, respectively. The UV spectroscopic method showed excellent linearity with a high correlation coefficient of 0.998 and 0.996 for 0.1N HCl and a phosphate buffer(pH-6.8) in the 2–20 μg/mL concentration range. Beer’s principle was followed in the 2–20 μg/mL concentration range. Precision studies revealed minimal variability, both within and between assay runs, while recovery studies confirmed high accuracy. The method’s specificity was validated by the absence of interference from excipients, and its robustness was confirmed through small deliberate variations in experimental conditions, with no significant impact on performance. This UV spectroscopy method presents a practical, highly accurate, and reproducible approach for analyzing gepirone hydrochloride in pharmaceutical formulations, ensuring both regulatory compliance and the maintenance of drug quality.