Quantitative estimation of mebeverine hydrochloride in sustained-release dosage form using an analytical lifecycle management oriented stability-indicating LC method

Abstract

A new liquid chromatographic method with stability-indicating potential was developed and validated for estimation of mebeverine hydrochloride in formulations using lacidipine as internal standard. A contemporary approach of analytical life-cycle management was followed to develop a robust and reliable chromatographic method. Scouted method variables such as % acetonitrile, flow rate and pH were optimized using design of experiment approach and their effect on critical quality attributes was studied. The attributes viz. resolution and theoretical plates of mebeverine, were highly influenced by % acetonitrile and flow rate of mobile phase. Chromatographic method specificity was ensured by degrading the drug forcefully. Validation studies postulated method acceptability and suitability for estimating mebeverine in both bulk as well as tablet formulation. Results for parameters viz. linearity (0.5–150 µg/mL), accuracy (>98%) and precision (<2%) advocated method reliability. Overall the method was reliable and of optimum quality and, possess the potential of application in routine and bio-analytical purposes.

Graphical Abstract

Keywords:

• Life cycle management
• mebeverine
• ultrafast liquid chromatography
• Box-Behnken Design
• control charts

Acknowledgements

The authors are thankful to Principal, Roland Institute of Pharmaceutical Sciences, Berhampur for providing the necessary research facilities.

Disclosure statement

No potential conflict of interest was reported by the authors.