Abstract
Aim: The current project involves developing an RP-HPLC method for simultaneous quantification of Candesartan Cilexetil and Pioglitazone based on analytical quality by design (AQbD). Materials and methods: When analysed in the Design Expert application, the critical method parameters were systematically refined using Central Composite Design and contours were derived for significant variables. A contour plot has been used to discover the technique operable design region that governs response variation, which is then empirically tested. Results: Successful chromatographic separation of title analytes was achieved on kromasil C18 (150 × 4.6 mm, 5 µm) column at 30 °C with mobile phase comprising 60% 20 Mm Potassium dihydrogen orthophosphate and 40% acetonitrile (v/v), isocratic elution pattern, 0.9 mL/min flow rate, and UV detection at 220 nm. The linear model for Candesartan Cilexetil was from 4 to 24 µg/ mL and Pioglitazone at 7.5–45 µg/ mL, respectively. Conclusion: The method met all the ICH Q2 (R1) validation criteria. The current approach aided for analysing simultaneous drugs can be expanded into quantifying drugs in biological matrix predominance with maximum recovery.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
