. Carry out the method for high performance liquid chromatography, Appendix 4.3, using the following solutions protected from light,

Uniformity of content:Comply with the requirements staled under Tablets using the following method of analysis. Carry out the method for high performance liquid chromatography, Appendix 4.3, using the following solutions protected from light, For solution (1) powder one tablet and dissolve as completely as possible In 5 ml of water and add 5 ml of a 0.006% w/v solution of hydrocortisone (internal standard) In methanol. Solution (2) is a mixture of equal volumes of a solution containing 0.0065% w/v of betamethasone sodium phosphate RS in water and a 0.006% w/v solution o1 hydrocortisone in methanol. The chromatographic procedure may be carried out using (a; a stainless steel column (20 cm n 4.6 mm) packed with stationary phase LCI (Spherisorb DCS 1 is suitable) an(maintained at 60°, (b) a mixture of 55 volumes of citro-phosphate buffer pH 5.0 and 45 volumes of methanol as the mobile phase with a flow rale of 2 ml per minute and (c) a detection wavelength of about 241 run Calculate the content of C22H29FQ5 in each tablet from the declared content of C22H29FQ5 in betamethasone sodium phosphate RS Other requirements;Comply with the requirements of tests slated under Tablets Assay:Carry out the method for high performance liquid chromatography, Appendix 4.3,using the following solutions protected from light For solution (1) weigh and powder 20 tablets. To a quantity of the powder equivalent to 2.5 mg of betamethasone add 25 ml of water and 5 ml of a 0.006% w/v solution of hydrocortisone (internal standard) in methanol. Solution (2) is a mixture of equal volumes of solution, of0.0065% w/v of betamathasona sodium phosphate RS in water and 0.006% w/v of hydrocortisone in methanol Carry out the chromatographic procedure described under Uniformity of content Calculate the content of C22H29FO5 in the tablets from the declared content of C22H29FO5 in betamethasone sodium phosphate RS. BFTAMETHASONE VALE RATE Bet am etnas one Valerate is a 9-fluoro-11B,21-dihydroxy-16Bmethyl-3,2G-dioxo-l,4pregnadien-l7-yl valerate Category:Adrenocomcal steroid.Description White to creamy-white powder:Solubility Freely soluble m chloroform;soluble in ethanol (95%); practically insoluble in water and in light petroleum Storage:Store in well-closed, light-resistant containers.STANDADRDS Befamethasone Valerale contains nol less than 96.0 per cent and not more than 102.0 per cent of C27H37FO6 calculated with reference to the dried substance Identification: A:The infra-red absorption spectrum, Appendix 54, is concordant with the reference spectrum ofbetamethasone vaterate or with the spectrum obtained from betamethasone valerale RS.B: Complies with the test for identification of steroids. Appendix- 3.6. using solvent I and mobile phase B and applying to the plate 1 ul of each of the solutions.C: In the Assay, the retention time of the principal peak in the chromatograrn obtained with solution (1) corresponds to that of the peak due to betamethasone valerate RS in the chromatogram obtained with solution (2). D. Heat 50 mg with 2 ml of 0.5M ethonolic potassium hydroxide in a water-bath for 5 minutes.Cool, add 2 ml of sulphuric acid (50% v/v) and boil gently for 1 minute; the odour of ethyl valerate is perceptible Specific optical rotation Between +75° and 462, determined in a 1 % w/v solution in dioxan. Appendix 8.9 Light absorption: Absorbance of a 0.002% w/v solution in ethanol at the maximum at about 240 nm, 0.63 to 0.67, Appendix 5.5 Related foreign steroids: Complies with the test for related foreign steroids. Method B. Appendix 3:7. using for solution (3) 0.03% w/v each of betamethasone RS and betamethasone valerale RS.Sulphated ash: Not more than 0.1%, Appendix 3.22 Loss on drying Not more than 0.5%, determined on 1 g by drying in an oven at 105", Appendix 8.6.Assay: Carry out the method for high performance liquid chromatography. Appendix 4.3, using Ihe following solutions. For solution [1) mix S ml of a 0.06% w/v solution of the substance being examined in methanol containing 0.1 % v/v glacial acetic acid and 10 ml of a 0.04% w/v solution of bedomethasone dipropionate RS (internal standard) in methanol containing 0.1% v/v of glacial acetic acid. For solution (2) mixture 55 ml of a 0 06% w/v solution of belarnethasone valerate RS in methanol containing 0.1 % v/v of glacial acetic acid and 10 ml of a 0.04% w/v solution of bedomethasone dipropionate RS in methanol containing 0.1 % v/v of glacial acetic acid.Carry out the chromalographic procedure using (a) a stainless steel column (30 cm x 4.0 mm) packed with stationary phase LC], (b) a mixture of 50 volumes of acetonitrile and 40 volumes of water as the mobile phase with a flow rate of 1.2 ml per minute and (c) a detection wavelength of about 240 run The relative retention times should be about 1.7 for beclomethasone dipropioate and 1.0 for betamethasone valerate.Calculate the content of C27H37FO5 from the declared content of C27-H37-FO6 in betamethasone valerate RS BETAMETHASONE VALERATE QINTMENTBetamethasone Valerate Ointment contains Betamethasone Valerate in a suitable ointment base.Usual strengths The equivalent of 0.025% w/w and 0.1% w/w of betamethasone (120 mg of Belamethasone Valerate is approximately equivalent to 100 mg of betamethasone). Storage Store in well-closed, light-resistant containers. Avoid exposure to excessive heat. Labelling: The label states the strength in terms of the equivalent amount of