Abstract

DEVELOPMENT AND VALIDATION OF MISOPROSTOL IN 0.1N HCL BY USING UV-SPECTROPHOTOMETRIC METHOD IN BULK FORM

Gandi Anusha*, Y. Srinivasa Rao, K. Varaprasada Rao and N. V. N. Koteswara Rao

.

Abstract

Objectives: The present study main objective is to evolve and validate stability indicating rapid, easy, economical and specific UV spectroscopic method for the estimation of misoprostol in bulk form which was used as NSAID related ulcers treatment. Materials & Methods: Only the Bulk form are used in this method development 0.1N HCL is used as a solvent for this study after several pre-solubility tests and several dilutions are made for the results evaluation. ELICODouble beam SL-120/UV spectrophotometer is used for the validation and method development under certain specifications. Predicated on the physical parameters and solubility of the misoprostol, solution of standard stock of the drug was composed and absorbance maxima were set on. The wavelength maxima of misoprostol occurs at 281nm. The linearity is done by preparing the solutions from 2-10 μg/ml. The study done for the development and validation is according to Q3D guidelines which are framed in ICH. Results: At a certain concentration the maximum absorbance, linearity of the compound is obtained by obeying Beers law. The correlation coefficient of the drug is below 1.The limit of detection & limit of quantification of misoprostol was found to be 0.656 μg/ml and 1.988 μg/ml. Accuracy and precision of the method is within the acceptance range after by recovery studies. Conclusion: By the interpreted results of various validated parameters, it is concluded that the developed method is rapid, simple, cost-effective method and suitable for quantitative determination of misoprostol in bulk form.

Keywords: Misoprostol, Spectroscopy, Materials and Methods, Method development.