Vishal Bharat Babar1,*, Srikanth Kumar Karumanchi2, B. Siva Sai Kiran3
1*Dattakala College of Pharmacy, Swami-Chincholi, Bhigwan-413130, Pune Dist., Maharashtra, India.
2V. V. Institute of Pharmaceutical Sciences, Gudlavalleru-521356, Krishna Dist., Andhra Pradesh, India.
3JNTUA-Oil Technological & Pharmaceutical Research Institute, Ananthapuramu-515002, Andhra Pradesh, India.
A B S T R A C T
In this study, the active pharmaceutical components of Zopolrestat and Pregabalin in their bulk dosage forms were to be measured using a unique, straightforward, responsive, and stable RP-HPLC method that was being developed and gradually validated. For the quantitative determination of Zopolrestat and Pregabalin, a straightforward, specific, verified, and well-defined stability that exhibits gradient RP-HPLC approach has been developed. The Agilent C18 (4.6 x 150mm, 5 m) was used for the chromatographic method, which involved isocratic elution with a mobile phase made up of orthophosphoric acid (0.1%) and acetonitrile (40:60% v/v). The instrument parameters called for a flow rate of 1 ml/min and a detection wavelength of 241 nm using the UV detector. The chromatographic method was expedited using the impurity-spiked solution. The proposed method’s validity was examined in accordance with the international conference on harmonization (ICH) guidelines. In relation to test concentration, LOD and LOQ were determined for the two active components and their contaminants. The plotted calibration charts had linear regression coefficients of 0.999, indicating that their linearity was within acceptable bounds. As part of the technique validation, recovery, specificity, linearity, accuracy, robustness, and ruggedness were assessed, and the findings were found to be within the acceptable range. The suggested approach is quick, easy, practical, and reasonably priced. It can be used for routine manufacturing sample analysis during stability tests and to confirm the calibre of medication samples during stability studies.
Keywords: Zopolrestat, Pregabalin, Method development, RP-HPLC, Validation