Sunday, August 2, 2009

solution of homatropine hydrobromide RS (internal standard) in methanol (solution A), extract with two quantities, each of 5 mL of chloroform and disc

006% w/v solution of homatropine hydrobromide RS (internal standard) in methanol (solution A), extract with two quantities, each of 5 mL of chloroform and discard the chloroform extracts Add 1 ml of 5M ammonia. Extract with two quantities, each of 5 ml, of chloroform, shake the combined extracts with 1 g of anhydrous sodium sulphate, filter and evaporate the filtrate to dryness. Dissolve the residue in 0.5 ml of a mixture of 20 volumes of diehloromethane 4 volumes of N,O-bis(trimethylsilyl)acetamide and 1 volume of trimethylchlorosilane, mix and allow to stand for 30 minutes. For solution (2) add 1 ml of solution A and 1 ml of 5M ammonia to 5 ml of a 0.012% w/v solution of atropine sulphate RS. Extract with two quantities, each of 5 ml, of chloroform and complete the procedure described under solution (1) beginning at the words "shake the combined extracts with 1 g of anhydrous sodium sulphate,". Prepare solution (3) in the same manner as solution (2) but omitting the addition of solutionA.The chromatographic procedure described under Assay in Atropine Sulphate Eye Ointment may be used. Calculate the content Of (C17H23NO3)2.H2SO4,H2O from the declared content of (C17H23NO3)2.H2SO4,H2O in atropine sulphate RS. Other requirements: Comply with the requirements of rests stated under Tablets. Assay. Weigh and powder 20 tablets. Carry out the method for gas chromatography, Appendix 4.2. For solution (1) shake a quantity of the powdered tablets equivalent to 5 mg of Atropine Sulphate with 10 ml of 0.1 M hydrochloric acid, add 1 ml of a 0.5% w/v solution of homatropine hydrobromide RS (internal standard) in methanol (solution A) extract with two quantities, each of 10 ml, of chloroform and discard the chloroform extracts Add 1 ml of Slvl ammonia. Extract with two quantities, each of 10 ml. of chloroform

No comments:

Post a Comment