Poldine Tablets
Action and use
Anticholinergic.
Definition
Poldine Tablets contain Poldine Metilsulfate.
Content of poldine metilsulfate, C22H29NO7S
90.0 to 110.0% of the stated amount.
Identification
Shake a quantity of the powdered tablets containing 2 mg of Poldine Metilsulfate with 10 mL of water and allow to stand. Decant the supernatant liquid, add 20 mL of ammonium cobaltothiocyanate solution and 5 mL of chloroform and shake well. The chloroform layer becomes blue.
TESTS
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
5 volumes of formic acid, 5 volumes of water, 30 volumes of methanol and 60 volumes of chloroform.
In the chromatogram obtained with solution (1):
any pink secondary spot is not more intense than the spot in the chromatogram obtained with solution (2) (1%).
Disregard any brown spots due to excipients in the chromatogram obtained with solution (1).
Assay
Weigh and powder 20 tablets. Shake a quantity of the powder containing 2 mg of Poldine Metilsulfate with 10 mL of water for 10 minutes and allow to stand. To 5 mL of the supernatant liquid add 20 mL of ammonium cobaltothiocyanate solution, shake vigorously for 1 minute and allow to stand for 5 minutes. Extract with four 5-mL quantities of chloroform, add to the combined extracts sufficient chloroform to produce 25 mL and centrifuge. Measure the absorbance of the clear, chloroform solution at the maximum at 322 nm, Appendix II B. Repeat the operation using 5 mL of a 0.02% w/v solution of poldine metilsulfate BPCRS beginning at the words ‘add 20 mL …’. Calculate the content of C22H29NO7S in the tablets from the absorbances obtained using the declared content of C22H29NO7S in poldine metilsulfate BPCRS.