DEVELOPMENT AND VALIDATION OF MISOPROSTOL BY USING UV-SPECTROPHOTOMETR

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.