Abstract

DEVELOPMENT AND VALIDATION OF SIMPLE AND VERY SENSITIVE HPLC METHOD WITH UV DETECTION FOR MISOPROSTOL- 0.1 MG TABLETS

*Manikya Rao T, T. Prabhakar, Dr. G Girija sankar, Srinivasarao Potnuru and PVL Naidu.

Abstract

A selective HPLC method with ultraviolet detector was described for the determination of Misoprostol 0.1 mg tablets by invitro dissolution study. After a confined dissolution period the misoprostol present in the aliquots of dissolution media was derivatized by methanolic potassium hydroxide. The technique involves the conversion of misoprostol to its derivative which will show maximum absorbance at 285nm. The chromatographic separation was performed using reversed phase, Thermo MOS Hypersil, 150x4.6mm, 5µ column. The mobile phase was composed of 50 volumes of buffer and 50 volumes of methanol, the buffer consisting of 10 ml triethylamine in 1000 ml of water adjusted to pH 6.0 + 0.05 with ortho-phosphoric acid, the detector used is a simple ultraviolet detector and the monitored wavelength is 285nm. The method is subjected for monitoring the parameters like specificity, accuracy, precision, linearity, ruggedness, robustness and solution stability. All the parameters are found to be at very appreciable level.

Keywords: Misoprostol, Tablets, Dissolution method, U V Detection, High performance liquid chromatography.