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Vol. 29 No. 12 (2017): Vol 29 Issue 12

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Application of Quality by Design for Development and Validation of RP-HPLC Method for Lercanidipine Hydrochloride

https://doi.org/10.14233/ajchem.2017.20905
Chandrakant Bonde
SVKM's NMIMS School of Pharmacy and Technology Management, Shirpur Campus, Shirpur-425 405, India
Smita Bonde
SVKM's NMIMS School of Pharmacy and Technology Management, Shirpur Campus, Shirpur-425 405, India
Jineet Kumar Gawad
SVKM's NMIMS School of Pharmacy and Technology Management, Shirpur Campus, Shirpur-425 405, India

Corresponding Author(s) : Jineet Kumar Gawad

jineetkumar.gawad@nmims.edu

Asian Journal of Chemistry, Vol. 29 No. 12 (2017): Vol 29 Issue 12

Abstract

Current research deals with the development of accurate, precise and robust analytical liquid chromatographic method for lercanidipine hydrochloride by application of quality by design (QbD). The key objective of research was to monitor the factors affecting the quality of analysis and also to identify the conditions where an adequate separation in minimal analysis duration could be achieved within a robust region. Basic process parameters which have the most impact on method performance were defined as proportion of acetonitrile in the mobile phase, pH of the aqueous phase and the flow rate. Quality by design (QbD) approach provided quantitative process knowledge which can be used to identify the HPLC instrument parameter settings that provided optimum chromatographic performance. The method optimization was accomplished using Fusion AETM software (SMatrix Corporation, Eureka, CA) in 2 phases. In Phase 1, rapid screening was done to reduce the number of independent variables followed by phase II where the method was optimized using a DOE approach. Response surface design was implemented for experimental robustness testing and the method is validated to verify the adequacy of selected ideal chromatographic conditions: the analytical column of phenomenex C18 (250 mm × 4.6 mm, 5 μm particle size), mobile phase consist of acetonitrile-aqueous phase (10 mM phosphate buffer, pH adjusted to 4.5, (Gradient, organic phase 82 to 95 % v/v), pump flow rate 1.2 mL/min, and wavelength of detection 236 nm. The quality by design (QbD) based method development helped in better understanding of the overall method capabilities and limitations and ensured a greater chance of effective method validation.

Keywords

Quality by design Lercanidipine hydrochloride Liquid chromatography
Bonde, C., Bonde, S., & Gawad, J. K. (2017). Application of Quality by Design for Development and Validation of RP-HPLC Method for Lercanidipine Hydrochloride. Asian Journal of Chemistry, 29(12), 2785–2793. https://doi.org/10.14233/ajchem.2017.20905
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