Mebeverine Tablets

General Notices

Action and use

Smooth muscle relaxant; antispasmodic.

Definition

Mebeverine Tablets contain Mebeverine Hydrochloride. They are coated.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of mebeverine hydrochloride, C25H35NO5,HCl

95.0 to 105.0% of the stated amount.

Identification

A. Suspend a quantity of the powdered tablets containing 0.2 g of Mebeverine Hydrochloride in 20 mL of water, add 5 mL of 5m sodium hydroxide and extract with two 25 mL quantities of chloroform. Dry the combined extracts over anhydrous sodium sulfate and evaporate to dryness using a rotary evaporator. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of mebeverine (RS 208).
B. The light absorption, Appendix II B, in the range 230 to 350 nm of the final solution obtained in the Assay exhibits a maximum at 263 nm and a less well-defined maximum at 292 nm.

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°.