Atropine Tablets

General Notices

Action and use

Anticholinergic.

Definition

Atropine Tablets contain Atropine Sulfate.

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

Content of atropine sulfate, (C17H23NO3)2,H2SO4,H2O

90.0 to 110.0% of the stated amount.

Identification

A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Shaking a quantity of the powdered tablets containing 10 mg of Atropine Sulfate with 2 mL of ethanol (96%), centrifuge and use the supernatant liquid.
(2) 0.5% w/v of atropine sulfate BPCRS in ethanol (96%).
chromatographic conditions
(a) Use as the coating silica gel G.
(b) Use the mobile phase as described below.
(c) Apply 5 µL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, heat it at 105° for 20 minutes, allow to cool and spray with dilute potassium iodobismuthate solution.
mobile phase

10 volumes of diethylamine, 40 volumes of acetone and 50 volumes of chloroform.

confirmation

The spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).

B. In the test for Uniformity of content, the chromatogram obtained with solution (1) exhibits a peak with the same retention time as the peak due to atropine sulfate in the chromatogram obtained with solution (2).

Tests

Uniformity of content

Tablets containing less than 2 mg and/or less than 2% w/w of Atropine Sulfate comply with the requirements stated under Tablets using the following method of analysis.

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1) Shake 1 tablet with 2 ml of the mobile phase with the aid of ultrasound until fully disintegrated and filter.
(2) 0.03% w/v of atropine sulfate BPCRS and 0.03% w/v of homatropine hydrobromide BPCRS in the mobile phase.
chromatographic conditions
(a) Use a stainless steel column (10 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 2 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 257 nm.
(f) Inject 20 µL of each solution.
mobile phase

0.01m sodium acetate and 0.005m dioctyl sodium sulfosuccinate in methanol (60%) adjusted to pH 5.5 with glacial acetic acid.

system suitability

The test is not valid unless, in the chromatogram obtained with solution (2), the resolution between the peaks due to atropine sulfate and homatropine hydrobromide is at least 2.5.

determination of content

Calculate the content of (C17H23NO3)2,H2SO4,H2O in each tablet using the declared content of (C17H23NO3)2,H2SO4,H2O in atropine sulfate BPCRS.

Assay

Use the average of the individual results determined in the test for Uniformity of content.