Mebeverine Tablets
Action and use
Smooth muscle relaxant; antispasmodic.
Definition
Mebeverine Tablets contain Mebeverine Hydrochloride. They are coated.
Content of mebeverine hydrochloride, C25H35NO5,HCl
95.0 to 105.0% of the stated amount.
Identification
Test
Related substances
Comply with the requirement stated under Mebeverine Hydrochloride using the following solutions. For solution (1) shake a quantity of the powdered tablets containing 0.2 g of Mebeverine Hydrochloride with 10 mL of acetone and filter. For solution (2) dilute 1 volume of solution (1) to 200 volumes with acetone. Solution (3) contains 0.01% w/v of veratric acid in acetone.
Assay
Weigh and powder 20 tablets. Heat a quantity of the powdered tablets containing 0.5 g of Mebeverine Hydrochloride with 100 mL of 0.1m hydrochloric acid for 10 minutes on a water bath, shaking occasionally. Cool, add sufficient 0.1m hydrochloric acid to produce 250 mL and filter. To 10 mL of the filtrate add sufficient 0.1m hydrochloric acid to produce 100 mL and dilute 15 mL of the resulting solution to 100 mL with the same solvent. Measure the absorbance of the solution at the maximum at 263 nm, Appendix II B. Calculate the content of C25H35NO5,HCl taking 263 as the value of A(1%, 1 cm) at the maximum at 263 nm.
Storage
Mebeverine Tablets should be kept in an airtight container, protected from light and stored at a temperature not exceeding 30°.