IDENTIFICATION, METHOD DEVELOPMENT AND METHOD VALIDATION FOR THE PROCESS AND DEGRADATION IMPURITIES OF VARDENAFIL HCl BY RP-UPLC AND UPLC-TOF
AbstractThis 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.
Article Information
12
107-119
1341
1637
English
IJPSR
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
kaviraj@drreddys.com
06 July, 2016
25 August, 2016
26 October, 2016
10.13040/IJPSR.0975-8232.8(1).107-19
01 January, 2017
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