DEVELOPMENT AND VALIDATION OF MISOPROSTOL BY USING UV-SPECTROPHOTOMETR.

      Аннотация: The present study aimed to develop and validate a stability-indicating UV spectroscopic method for the quantification of misoprostol in bulk form, which is commonly used for treating NSAID-related ulcers. The study used only the bulk form of misoprostol and selected 0.1N HCl as the solvent after conducting pre-solubility tests. The method was developed and validated using the ELICO-Double beam SL-120/UV spectrophotometer. Based on the physical parameters and solubility of misoprostol, a standard stock solution of the drug was prepared, and the absorbance maxima were determined to occur at 281nm. Linearity was established by preparing solutions ranging from 2-10 µg/ml, and the study followed the Q3D guidelines outlined by the ICH.The developed UV spectroscopic method for misoprostol quantification in bulk form proved to be rapid, simple, cost-effective, and suitable for its specific determination. The method adhered to established guidelines and exhibited good linearity, with satisfactory LOD, LOQ, accuracy, and precision.

Ключевые слова: Misoprostol, method development, Method Validation parameters, UV Spectrophotometer, 0.1N Hydrochloric acid