STABILITY INDICATING UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE IN BULK DRUG AND PHARMACEUTICAL FORMULATION

Abstract

Background and Aim: The current study attempted to invent and evaluate an easy and sensitive Stability indicating UV spectrophotometric method for simultaneous determination of Glimepiride and Pioglitazone HCl. Material and Methods: To provide a simple, sensitive, robust, precise, and accurate Stability indicating UV-Spectrophotometric method for the simultaneous estimate of Glimepiride and Pioglitazone HCl, as well as to develop a combined tablet dosage formulation of Glimepiride and Pioglitazone HCl. The best conditions for drug analysis were found using Methanol as the solvent. Results and Discussion: Glimepiride and Pioglitazone Hydrochloride had maximum absorption wavelengths of 227.6nm and 266.8nm, respectively. Glimepiride and Pioglitazone Hydrochloride demonstrated linear responses between concentration ranges of 2-12g/ml and 5-30g/ml, respectively. It was discovered that the linear regression coefficient was 0.999. According to ICH criteria, the method was validated for sensitivity, specificity, range and linearity, precision, and ruggedness, all validation results were found to be within acceptable limits. Glimepiride and pioglitazone HCl were exposed to forced degradation under ICH guidelines. The resulting samples were used for deterioration experiments utilizing the established procedure. Conclusion: As a result, it may be argued that the procedure was novel, straightforward, precise, specific, and selective for the simultaneous estimation of Glimepiride and Pioglitazone HCl in bulk Drugs.