Analytical method development and Validation for the Estimation of Avacopan in bulk and capsuledosage form by RP-HPLC

Abstract

In the modern pharmaceutical industry, high-performance liquid chromatography (HPLC) is the major and integral analytical tool applied in all stages of drug discovery, development and production. It is ideal for the analysis of many drugs in both dosage forms and biological fluids due to its simplicity, high specificity and good sensitivity. A new method was established for estimation of Avacopan RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Avacopan. The maximum absorbance was found to be at 257 nm and the peak purity was excellent.  Injection volume was selected to be 10µl which gave a good peak area. The column used for study was Develosil ODS HG-5 RP C18, 5µm, 15cmx4.6mm because it was giving good peak. Ambient temperature was found to be suitable for the nature of drug solution. The flow rate was fixed at 1.0ml/min because of good peak area and satisfactory retention time. Mobile phase is Acetonitrile: Water (70:30% v/v) was fixed due to good symmetrical peak. So this mobile phase was used for the proposed study. Run time was selected to be 2.21 min and Retention Time found to be 2.286, % RSD was reported as 0.663419.  The Minimum concentration level at which the analyte can be reliable detected (LOD) & quantified (LOQ) were found to be 0.05 & 0.15 µg/ml respectively.. Avacopan was degraded in acidic, basic & 3 % hydrogen peroxide & stable at thermal & light stress conditions.The method was robust and rugged as observed from insignificant variation in the results of analysis by changes in Flow rate and Mobile phase composition separately and analysis being performed by different analysts. The suggested RP-HPLC method can be used for routine analysis of Avacopan in API and Pharmaceutical dosage form.