A NEW VALIDATED CHIRAL RP-HPLC METHOD FOR THE DETERMINATION OF STABILITY OF MEBEVERINE ENANTIOMERS IN THE PRESENCE OF ITS DEGRADATION PRODUCTS
Keywords:
Stability-indicating method, Validation, Chiral, MebeverineAbstract
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
Downloads
References
Ahuja S. Impurities Evaluation of Pharmaceuticals. Marcel Dekker Inc: New York USA; 1998. p. 142.
Ahuja S, Alsante KM. Handbook of isolation and characterisation of impurities in pharmaceuticals. Academic Press San Diego USA; 2003.
Baaske DM, Demay JF, Latona CA, Mirmira S, Sigvardson KW. Stability of nicardipine hydrochloride in intravenous solutions. Am J Health Syst Pharm 1996;53(14):1701-5.
Daraghmeh N, Al-Omari M, Badwan AA, Jaber AM. Determination of sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC. J Pharm Biomed Anal 2001;25(3-4):483-92.
Pettersson C, Persson B. In: Katz E, Eksteen R, Schoenmakers P, Miller N (Eds). Handbook of HPLC Marcel Dekker, New York; 1998. p. 669.
Souri E, Negahban Aghdami A, Adib N. A stability indicating HPLC method for determination of mebeverine in the presence of its degradation products and kinetic study of its degradation in oxidative condition. Res Pharm Sci 2014;9(3):199-206.
Gowramma B, Meyyanathan SN, Gomathy S, Babu B, Krishnaveni N, Suresh B. Stability indicating chiral HPLC method for the estimation of zaltoprofen enantiomers in pharmaceutical formulation. Int J Pharm Pharm Sci 2014;6(2):584-7.
Saranjith Singh, Monical Baksh. Development of validated stability-indicating assay methods-critical review. J Pharm Biomed Anal 2002;28(6):1011-40.
ICH Q1A stability testing of new drug substances and products. International Conference on Harmonization IFPMA Geneva; 1993.
Ritchie JA, Truelove SC. Comparison of various treatments for irritable bowel syndrome. Br Med J 1980;281(6251):1317-9.
Evans PR, Bak YT, Kellow JE, Mebeverine alters small bowel motility in irritable bowel syndrome. Aliment Pharmacol Ther 1996;10(5):787-93