Validated stability indicating method for determination of umifenovir- remdesivir in presence of its degradation products
International Journal of Development Research
Validated stability indicating method for determination of umifenovir- remdesivir in presence of its degradation products
Received 18th January, 2021; Received in revised form 16th February, 2021; Accepted 20th March, 2021; Published online 22th April, 2021
Copyright © 2021, Srinivasa Rao Surabhi and Dr. Neelu Jaina. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
A simple stability indicating reverse-phase high performance liquid chromatographic (RP-HPLC) method has been developed for the determination of Umifenovir and Remdesivir in its tablet dosage form. The chromatographic solution was optimized by using the standard solution. The chromatographic method was used by Zorbax SB C18 column of dimensions 150x4.6 mm, 3.5 microns, using isocratic elution with a mobile phase of acetonitrile and water with a 50:50 ratio was used for the chromatographic separation and was monitored at a wavelength 230 nm PDA detector with flow rate 1 ml/min. The total run time was 10 min. According to the ICH guidelines, the developed approach was validated. The calibration charts plotted were linear with a regression coefficient of R2 > 0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range. All the degradation products generated during the stress conditions are well separated and peaks have been well resolved with an acceptable retention period indicating that the proposed method was fast, easy, feasible and affordable.
