DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF NETUPITANT AND PALONOSETRON IN CAPSULEAbstract
A simple, accurate, and precise stability-indicating method was developed for the simultaneous estimation of the Netupitant (NTPT) and Palonosetron (PLSN) in a capsule by UPLC. Chromatographic elution was processed through an HSS C18 (100 × 2.1 mm, 1.8m) reverse phase column, and the mobile phase composition of 0.01N KH2PO4 buffer (4.0 pH) and acetonitrile in the ratio of 55:45 was pumped through a column at a flow rate of 0.3 ml/min. The column oven temperature was maintained at 30 °C, and the detection wavelength was processed at 274 nm. Retention times of NTPT and PLSN were found to be 1.682 min and 1.288 min, respectively. Repeatability of the method was determined in the form of %RSD, and findings were 0.9 and 1.0 for NTPT and PLSN, respectively. The percentage recovery of the method was found to be 99.98% and 99.61% for NTPT and PLSN, respectively. LOD, LOQ values obtained from regression equations of NTPT and PLSN were 2.174, 6.587mg/ml and 0.02, 0.05 mg/ml respectively. Regression equation of NTPT was y = 4923.1x ± 1915.4 and PLSN was y = 40065x ± 224.19. Two analytes were subjected for acid, peroxide, photolytic, alkali, neutral, and thermal degradation studies, and the results show that the percentage of degradation was found between 0.85% and 6.50%. Retention times and total run time of two drugs were decreased, and the developed method was simple and economical. So, the developed method can be adopted in industries as a regular quality control test for the quantification of NTPT and PLSN.
T. V. Raveendranath *, R. T. Saravanakumar and C. K. V. L. S. N. Anjana
Department of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu, India.
10 July 2020
20 November 2020
06 May 2021
01 July 2021