Sunday, August 2, 2009

Centrifuge, if necessary, to remove any insoluble material. Using this solution as solution (1), carry out the test described under

Betamethasone Dissolution. Comply with the dissolution test Centrifuge, if necessary, to remove any insoluble material. Using this solution as solution (1), carry out the test described under for tablets and capsules, Appendix 7.3. using as medium 900 ml of water and 1 ml of 0.05% w/v solution of testosterone RS (internal standard) in methanol and placing one tablet in the vessel for each test and rotating the paddle at 50 rpm for 45 minutes. Withdraw a suitable volume of the sample and filter. Carry out the method for high performance liquid chromatography, Appendix 4.3, using the filtrate as solution (1) For solution (2) dilute a mixture of 1 ml of each of a 0.05% w/v solution of betamethasone RS in methanol and 1 ml of a 0.05% w/v solution of testosterone RS in methanol to 900 mt with water. The chromatographic procedure may be carried out using (a) a column (30 cm x 3.9 mm) packed with stationary phase LCI. (b) a mixture of 60 volumes of methanol and 40 volumes of water as the mobile phase with a flow rate of 2 ml per minute and (c) a detection wavelength of about 254 run D: Not less than 75% of the stated amount of C22H29FO5. Uniformity of content.1 Comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for high performance liquid chromatography, Appendix 4.3, protected from light, using the following solutions in methanol (50%). For solution (1) finely crush one tablet, add 20 ml of a 0.002% w/v solution of hydrocortisone (internal standard) in methanol (50%), shake for 10 minutes and filter through a glass-fibre filter paper (Whatman GF/C is suitable) Solulion (2) contains 0.0025% w/v of betamethasone RS and 0.002% w/v of hydrocortisone. The chromatographic procedure may be carried out using (a) a stainless steel column (20 cm x 5 mm) packed with stationary phase LCI (Spherisorb ODS 1 is suitable), (b) a mixture of 53 volumes of water and 47 volumes of methanol as the mobile phase with a flow rate of 1.4 ml per minute and (c) a detection wavelength of about 238 nm. Calculate the content of C22H29FO5 in each tablet from the declared content of C22H29FO5 in betamethasone RS. Other requirements : Comply with the requirements of tests stated under Tablets Assay: Carry out the method for high performance liquid chromatography. Appendix 4.3, protected from light, usingthe following solutions in methanol (50%). For solution (1) weigh and powder 20 tablets Weigh accurately a quantity of the powder equivalent to 2.5 mg of Betamethasone, add 20 ml of methanol (50%), shake for 10 minutes and filter through a glass-fibre filter paper (Whatman GF/C is suitable). Solution (2) contains 0.0125% w/v of betamethasone RS and 0.01096 w/v of hydrocortisone RS (internal standard) Prepare solution (3) in The

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