A NEW VALIDATED CHIRAL RP-HPLC METHOD FOR THE DETERMINATION OF STABILITY OF MEBEVERINE ENANTIOMERS IN THE PRESENCE OF ITS DEGRADATION PRODUCTS
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 5
Abstract
Objective: An enantioselective reverse phase high performance liquid chromatographic method was developed and validated for the analysis of mebeverine enantiomers. This method was used to investigate the stability and degradation behaviour of mebeverine under different stress conditions recommended by International Conference on Harmonization (ICH).Methods: An Isocratic chiral RP-HPLC method for the resolution of mebeverine and its degradation products was successfully achieved on a Phenomenex® lux cellulose 1 column, using UV detector at wavelength of 219 nm, with a mobile phase consisting of 0.1% diethyl amine in methanol, 20 mM ammonium bicarbonate (pH: 4.6) adjusted with trifluroacetic acid, 0.1% diethyl amine in isopropyl alcohol (55: 15: 30 v/v/v), and a flow rate of 1.2 ml/min. The drug was subjected to alkaline, acidic, neutral, oxidative, and photolytic conditions in order to mimic stress conditions. The stressed samples were also analysed by this method.Results: The method developed provided the linear correlation (R2 =0.999) for the drug between a range of 56–84 µg/ml for (-) mebeverine and 52–78 µg/ml (+) mebeverine respectively. The limit of detection and limit of quantification of (-) mebeverine was found to be 0.30 µg/ml, 0.90 µg/ml and (+) mebeverine was found to be 0.32 µg/ml, 0.97 µg/ml respectively.Conclusion: The method developed was found to provides good sensitivity and excellent precision and reproducibility and can be applied in the quality control of drug products.Â
Authors and Affiliations
K. R. Senthil Kumar, S. N. Meyyanathan, B. Gowramma
Keywords
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