A NEW STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR TREPROSTINIL IN PHARMACEUTICAL DOSAGE FORM AND BULK BY USING CHROMATOGRAPHIC AND SPECTROSCOPY TECHNIQUE

Abstract

Simple, novel and selective reverse phase-high performance liquid chromatography (RP-HPLC) and ultraviolet (UV) spectroscopic methods have been developed and optimized for the determination of treprostinil in bulk and dosage form. In the Uv-Visible Spectroscopy The mobile phase consisted of Methanol in the ratio of 100v/v and the wavelength to maximum absorbance at 288.0 nm. Chromatogram was run through HPLC Column ZORBAX Eclipse, XDB-C18, 80Å, 5 μm, 4.6 x 150 mm 0.1% OPA and Methanol taken in the ratio 60:40 was pumped through column at a flow rate of 1.2ml/min. Temperature was maintained at 25°C. Optimized wavelength selected was 288.0nm. Retention time of treprostinil was found to be 2.232min. %RSD of the treprostinil were and found to be 0.1%. %RSD of Method precision of treprostinil was found to be 0.5%. %Recovery was obtained as 99.79% for treprostinil. LOD, LOQ values obtained from regression equation of treprostinil were 0.12, 0.38, Regression equation of treprostinil is y = 13118x + 975.5, Analytical calibration curves were linear within a concentration range from 2.5 to 15 μg/ml and coefficient of correlation 0.999. %RSD was found to be less than 2 respectively, in UV spectroscopic method, The developed methods were found to be simple, accurate, reproducible, and precise. The treprostinil can be analyzed in dual techniques, i.e., chromatographic and UV spectroscopic methods for its routine analysis.