DEVELOPMENT AND VALIDATION OF NOVEL RP- HPLC METHOD FOR SIMULTANEOUS ANALYSIS OF PREGABALIN AND DULOXETINE IN SYNTHETIC MIXTUREAbstract
A sensitive, rapid, precise and accurate RP-HPLC method was developed for simultaneous estimation of Pregabalin and Duloxetine in synthetic mixture. To introduce a chromophoric group in Pregabalin structure, derivatization was carried out through benzoylation reaction. RP- HPLC method is carried out using Hypersil BDS column C18 (250 cm × 4.6 cm, 5 μm). Mobile phase used as combination of Methanol: Water (75:25 v/v) and detection was carried out at 235 nm & 224 nm respectively for Duloxetine and Pregabalin. Retention time of Duloxetine and Pregabalin were found to be 2.15 min and 5.23 min, respectively. The developed method was validated in pursuance of ICH Q2 (R1) guidelines. Linearity range of Duloxetine is 50-100 μg/mL and for Pregabalin is 100-200 μg/mL. Correlation coefficient for both drugs was 0.999 and mean recoveries for both drugs were between 99% – 100%, minimum values of %RSD indicate the accuracy of the method. The detailed quantitative results show that this method is sensitive, precise as well as cost effective.
Ojash Patel * and Mona Patel
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, SSSRGI, Mehsana, Gujarat, India.
17 March 2023
09 May 2023
31 May 2023
01 November 2023