DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR LEVONORGESTREL IN PHARMACEUTICAL DOSAGE FORM

Abstract

Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method have been developed and validated for the estimation of levonorgestrel in Bulk drug and Pharmaceutical dosage form. The developed method is rapid, accurate, precise, simple and economical. The separation was carried out using Hypersil ODS C-18 (125 mm × 4.6 mm 5 ? particle size) , in isocratic mode, with mobile phase containing Acetonitrile: water (50:50, v/v). The flow rate is 1 ml / min and effluents are monitored at 243 nm. Chromatogram showed peak at a retention time of 4.3 min for levonorgestrel. The method is validated for system suitability, linearity, precision, accuracy specificity, ruggedness, robustness, LOD and LOQ. The calibration plot showed good linear relationship with r2 = 0.9999, in the concentration range of 1.2 -9.0 ?g/ml. LOD and LOQ were found to be 0.12 ?g/ml and 0.38 ?g/ml. Accuracy was found to be between 98.88-100.37 %. The drug undergoes degradation in acid, alkali, oxidation, etc. conditions. It can be employed as a stability indicating method.