Development and Validation of Mebeverine Hydrochloride Assay by RP-HPLC Method
DOI:
https://doi.org/10.37285/ijpsn.2018.11.5.3Abstract
A validated method for the estimation of the mebeverine hydrochloride, an anti-spasmodic agent, was developed which was simple, precise, rapid and accurate. A clear separated chromatographic peak was achieved on Apollo C18 (4.6x250 mm), 5-μm column. Mobile phase used in this separation was the mixture of methanol and water in the ratio of 90:10% v/v with a flow rate of 0.9 μL/min at ambient temperature. The detection was achieved at a wavelength of 265 nm. At the retention time of 3.9 min and tailing factor of 1.09, chromatographic peak was observed. As per the guidelines of ICH, the method was developed and was validated with respect to accuracy, linearity, specificity, precision and robustness. Correlation co-efficient obtained shows a good linear relationship of more than 0.998 in the concentration range of 5 μg to 30 μg. Mean % recovery of 99.2% was seen and %RSD for repeatability and intermediate precision was less than 2%. Therefore, the developed method can be used for the quantitative determination of mebeverine hydrochloride successfully in pharmaceutical dosage forms.
Downloads
Metrics
Keywords:
Mebeverine, Estimation, RP-HPLC, ICH guidelines, Assay
Downloads
Published
How to Cite
Issue
Section
References
Arayne MS, Sultana N and Siddiqui FA (2005). A new RP-HPLC method for analysis of mebeverine hydrochloride in raw materials and tablets. Pak J Pharm Sci 18(2): 11-14.
Connell AM (1965). Physiological and clinical assessment of the effect of the musculotropic agent mebeverine on the human colon. Br Med J 2(5466): 848.
Czechowicz S, McCulloch MW, Raper C and Rand MJ (1969). The mode of action of mebeverine, a spasmolytic agent. Pharmacol Res Commun; 1(3): 303-309.
Darvish-Damavandi M, Nikfar S and Abdollahi M (2010). A systematic review of efficacy and tolerability of mebeverine in irritable bowel syndrome. World J Gastroenterol 16(5): 547.
Elmasry MS, Blagbrough IS, Rowan MG, Saleh HM, Kheir AA and Rogers PJ (2011). Quantitative HPLC analysis of mebeverine, mesalazine, sulphasalazine and dispersible aspirin stored in a Venalink monitored dosage system with co-prescribed medicines. J Pharm Biomed Ana 54(4): 646-652.
Guideline IH (2005). Validation of analytical procedures: text and methodology Q2 (R1). International Conference on Harmonization, Geneva, Switzerland; pp-11-12.
Haggag RS, Shaalan RA and Belal TS (2010). Validated HPLC determination of the two fixed dose combinations (chlordiazepoxide hydrochloride and mebeverine hydrochloride carvedilol and hydrochlorothiazide) in their tablets. J AOAC Int 93(4): 1192-1200.
Jones RH, Holtmann G, Rodrigo L, Ehsanullah RS, Crompton PM, Jacques LA and Mills JG (1999). Alosetron relieves pain and improves bowel function compared with mebeverine in female nonconstipated irritable bowel syndrome patients. Aliment Pharmacol Ther 13(11): 1419-1428.
Kruis W, Weinzierl M, Schüssler P and Holl J (1986). Comparison of the therapeutic effect of wheat bran, mebeverine and placebo in patients with the irritable bowel syndrome. Digestion 34(3): 196-1201.
Naguib IA and Abdelkawy M (2010). Development and validation of stability indicating HPLC and HPTLC methods for determination of sulpiride and mebeverine hydrochloride in combination. Eur J Med Chem 45(9): 3719-3725.
Radwan MA, Abdine HH and Aboul-Enein HY (2006). A validated chiral HPLC method for the determination of mebeverine HCl enantiomers in pharmaceutical dosage forms and spiked rat plasma. Biomed Chromatogr 20(2): 211-216.
Srinivasan V, Sivaramakrishnan H, Karthikeyan B, Balaji TS and Vijayabaskar S (2011). Stress degradation studies on mebeverine hydrochloride and development of a validated stability indicating UPLC method. J Liq Chromatogr Relat Technol 34(16): 1631-1644.
Subissi A, Brunori P and Bachi M (1983). Effects of spasmolytics on K+-induced contraction of rat intestine in vivo. Eur J Pharmacol 96(3-4): 295-301.
