Atropine Tablets
Action and use
Anticholinergic.
Definition
Atropine Tablets contain Atropine Sulfate.
Content of atropine sulfate, (C17H23NO3)2,H2SO4,H2O
90.0 to 110.0% of the stated amount.
Identification
10 volumes of diethylamine, 40 volumes of acetone and 50 volumes of chloroform.
The spot in the chromatogram obtained with solution (1) corresponds to that 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.
0.01m sodium acetate and 0.005m dioctyl sodium sulfosuccinate in methanol (60%) adjusted to pH 5.5 with glacial acetic acid.
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.
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.