Poldine Tablets

General Notices

Action and use

Anticholinergic.

Definition

Poldine Tablets contain Poldine Metilsulfate.

The tablets comply with the requirements stated under Tablets and with the following requirements.

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.

(1) Add 4 mL of methanol to a quantity of the powdered tablets containing 20 mg of Poldine Metilsulfate, mix with the aid of ultrasound for 5 minutes, centrifuge and to 1 mL of the supernatant liquid add 0.2 mL of formic acid.
(2) Dilute 1 volume of solution (1) to 100 volumes with a mixture of 5 volumes of methanol and 1 volume of formic acid.
chromatographic conditions
(a) Use as the coating silica gel precoated plate (Merck silica gel 60 plates are suitable).
(b) Use the mobile phase as described below.
(c) Apply 50 µL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in air, spray with a 50% v/v solution of sulfuric acid and heat at 110° for 20 minutes.
mobile phase

5 volumes of formic acid, 5 volumes of water, 30 volumes of methanol and 60 volumes of chloroform.

limits

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.