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TOLPERISONE HYDROCHLORIDE TABLETS

Category Muscle relaxant.

      Tolperisone Hydrochloride Tablets contain not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of C16H23NO.HCl.

Strengths available 50 and 150 mg.

Dose Adults: 150 to 450 mg daily in three equally divided doses.

      Children 6 years of age and over: 2 to 4 mg per kg of body weight daily in three equally divided doses.

      Children younger than 6 years of age: 5 mg per kg of body weight daily in three equally divided doses.

Contra-indication; Warning See under Tolperisone Hydrochloride, p. 164.

Identification

      A. The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

      B. A filtered 5 per cent w/v solution of the tablets yields reaction A characteristic of chlorides (Appendix 5.1).

Piperidine Hydrochloride Not more than 1.0 per cent w/w. Carry out the test as described in the “Ultraviolet and Visible Spectrophotometry” (Appendix 2.2). Transfer an accurately weighed portion of the powdered tablets equivalent to 20.0 mg of tolperisone hydrochloride to a 10-ml volumetric flask. Add sufficient 0.1 M hydrochloric acid and shake for 20 minutes to dissolve. Dilute with 0.1 M hydrochloric acid to volume, mix and filter. Use this solution as the test solution. Proceed as directed in the Piperidine Hydrochloride described under Tolperisone Hydrochloride, p. 164, beginning with “ Separately, dissolve 20.0 mg of...”.

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.24).

      Dissolution medium: water; 900 ml.

      Apparatus 2: 75 rpm.

      Time: 45 minutes.

      Procedure Determine the amount of C16H23NO.HCl dissolved from absorbances at the maximum at about 260 nm of filtered portions of the test solution, suitably diluted with Dissolution medium, if necessary, in comparison with a standard solution having a known concentration of about 11 μg per ml of Tolperisone Hydrochloride RS in the same medium (Appendix 2.2).

      Tolerances Not less than 75 per cent (Q) of the labelled amount of C16H23NO.HCl is dissolved in 45 minutes.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).

      pH 4.0 Buffer solution Mix 5.0 ml of phosphoric acid and 5.0 ml of triethylamine in 800 ml of water and adjust with sodium hydroxide to a pH of 4.0. Dilute with water to make 1000.0 ml.

      Mobile phase Prepare a mixture of 650 volumes of pH 4.0 Buffer solution and 350 volumes of acetonitrile. Make adjustments if necessary.

      Standard preparation Dissolve an accurately weighed quantity of Tolperisone Hydrochloride RS in 0.1 M hydrochloric acid to obtain a solution having a known concentration of about 1 mg per ml. Transfer 5.0 ml of this solution to a 50-ml volumetric flask, dilute with Mobile phase to volume and mix.

      Assay preparation Weigh and finely powder not less than 20 Tolperisone Hydrochloride Tablets. Transfer an accurately weighed portion of the powder containing about 50 mg of tolperisone hydrochloride to a 50-ml volumetric flask. Add sufficient 0.1 M hydrochloric acid and shake for 20 minutes to dissolve. Dilute with 0.1 M hydrochloric acid to volume, mix and filter. Transfer 5.0 ml of the filtrate to a 50-ml volumetric flask, dilute with Mobile phase to volume and mix.

      Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (5 μm), (b) Mobile phase at a flow rate of about 1 ml per minute, and (c) an ultraviolet photometer set at 258 nm.

      To determine the suitability of the chromatographic system, chromatograph Standard preparation and record the peak responses as directed under Procedure: the symmetry factor for the tolperisone peak is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 per cent.

      Procedure Separately inject equal volumes (about 10 μl) of Standard preparation and Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

      Calculation Calculate the content of C16H23NO.HCl in the portion of the Tablets taken, using the declared content of C16H23NO.HCl in Tolperisone Hydrochloride RS.

Other requirements Comply with the requirements described under “Tablets” (Appendix 1.16).

MONOGRAPHS • TOLPERISONE HYDROCHLORIDE TABLETS
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หมายเหตุ / Note : TP II 2011 PAGE 165 - 166