Atropine Injection

General Notices

Action and use

Anticholinergic.

Definition

Atropine Injection is a sterile solution of Atropine Sulfate in Water for Injections.

The injection complies with the requirements stated under Parenteral Preparations 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) Evaporate a volume of the injection containing 5 mg of Atropine Sulfate to dryness on a water bath, triturate the residue with 1 mL of ethanol (96%), allow to stand 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.
(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 Assay, 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

Acidity

pH, 2.8 to 4.5, Appendix V L.

Assay

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

For injections containing less than 0.1% w/v of Atropine Sulfate

(1) Use the injection being examined.
(2) Use atropine sulfate BPCRS and homatropine hydrobromide BPCRS in the mobile phase, both at the same concentration as the solution being examined.

For injections containing 0.1% w/v or more of Atropine Sulfate

(1) Dilute the injection, if necessary, to contain 0.1% w/v of Atropine Sulfate with water.
(2) 0.1% w/v of atropine sulfate BPCRS and 0.1% 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) For injections containing less than 0.1% w/v of Atropine Sulfate inject 100 µL of each solution. For injections containing 0.1% w/v or more of Atropine Sulfate 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 the injection using the declared content of (C17H23NO3)2,H2SO4,H2O in atropine sulfate BPCRS.