Abstract

METHOD DEVELOPMENT AND VALIDATION OF MEBEVERINE HCL IN BULK DRUGS BY RP-HPLC METHOD

Jagadeesh C. S., Senthilkumar G. P.* and Chandan R.

ABSTRACT

A simple, specific, quick, isocratic Reversed Phase High Performance Liquid Chromatographic method was developed and validated for the analysis of Mebeverine HCl. RP-HPLC method was developed on a X-Terra, C-8 (4.6 × 100 mm), 5 μm particle, reversed-phase column. The mobile phase was triethanolamine (pH- 3): acetonitrile, 40:60 (v/v) at a flow rate of 0.8 ml/min to get better reproducibility and repeatability. Quantification was achieved with UV detection at 271 nm based on peak area. The retention time was found to be 4.334 min. The method was linear over the range of 1-5 μg/ml with a regression coefficient of 0.999 and validated with respect to accuracy, precision, linearity and specificity, limit of detection and limit of quantization as per the guidelines of International Conference for Harmonization (ICH). This method can be used in the industries for determination of Mebeverine HCl to analyze the quality of formulation without interference of the excipients.

Keywords: Mebeverine HCl, RP-HPLC, validation, ICH.