IDENTIFICATION, METHOD DEVELOPMENT AND METHOD VALIDATION FOR THE PROCESS AND DEGRADATION IMPURITIES OF VARDENAFIL HCl BY RP-UPLC AND UPLC-TOFAbstract
This present work is on method development of assay and related substances of Vardenafil HCl and degradation of drug substance under acid, base hydrolysis and oxidation conditions. Identification of the impurities were done by the UPLC-TOF. Waters LCT Premier time of flight HRMS instrument with 5 ppm accuracy employed for degradation impurity identification. The validation of the method for its impurities was done in RP-UPLC chromatography as per the ICH Q2(R1) guidelines and the validation parameters such as specificity with all the process and degradation impurities, linearity, precision, accuracy, solution stability, mobile phase stability, robustness and ruggedness parameters met acceptance criteria as per ICH guidelines.
Kaviraj Yarbagi *, Nagaraju Rajana , J. Moses Babu, B. Venkateswara Rao and Paul Douglas
Dr. Reddy’s Laboratories Ltd., Bollaram road, Miyapur, Hyderabad, Andhra Pradesh, India
06 July, 2016
25 August, 2016
26 October, 2016
01 January, 2017