• British Pharmacopoeia Volume III
  • Formulated Preparations: Specific Monographs

Ergometrine Tablets

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General Notices
Action and use

Oxytocic.

Definition

Ergometrine Tablets contain Ergometrine Maleate.

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

Content of ergometrine maleate, C19H23N3O2,C4H4O4

90.0  to 110.0% of the stated amount.

Identification

A.  In the test for Related substances the principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (5).

B.  Extract a quantity of the powdered tablets containing 2  mg of Ergometrine Maleate with 20  ml of water, filter and wash the residue with sufficient water to produce 20  ml. The solution exhibits a blue fluorescence.

C.  To 2  ml of the solution obtained in test B add 4  ml of dimethylaminobenzaldehyde solution R6. A deep blue colour is produced after a few minutes.

Tests
Related substances

Carry out the method for thin-layer chromatography protected from light, Appendix III A, using a suspension of silica gel G in 0.1m sodium hydroxide to prepare the plate and a mixture of 90  volumes of chloroform and 10  volumes of methanol as the mobile phase. Apply separately to the plate 5 µl of each of the following solutions. For solution (1) triturate a quantity of the powdered tablets containing 1  mg of Ergometrine Maleate with 0.2  ml of a 1% w/v solution of domiphen bromide, add 2  ml of methanol, centrifuge and remove the supernatant liquid. Extract the residue with two 1  ml quantities of methanol, evaporate the combined extracts to dryness at 20° at a pressure of 2  kPa and dissolve the residue in 0.25  ml of methanol; centrifuge if necessary. Solutions (2), (3), (4) and (5) are solutions of ergometrine maleate BPCRS in methanol containing 0.010% w/v, 0.020% w/v, 0.040% w/v and 0.40% w/v respectively. After removal of the plate, allow it to dry in air and examine under ultraviolet light (365  nm). Assess the intensities of any secondary spots in the chromatogram obtained with solution (1) by reference to the spots in the chromatograms obtained with solutions (2), (3) and (4). The sum of the intensities so assessed does not exceed 10% of the intensity of the principal spot. In addition, no single secondary spot in the chromatogram obtained with solution (1) is more intense than the spot in the chromatogram obtained with solution (2).

Tablets containing less than 2  mg of Ergometrine Maleate comply with the requirements stated under Tablets using the following method of analysis. Carry out the following procedure protected from light. To one tablet add 10  ml of a 1% w/v solution of (+)-tartaric acid, shake for 30  minutes and centrifuge. Carry out the Assay described under Ergometrine Injection, beginning at the words 'Dilute a suitable volume…' and calculate the content of C19H23N3O2,C4H4O4.

Assay

Weigh and powder 20  tablets. Shake a quantity of the powder containing 2  mg of Ergometrine Maleate with 50  ml of a 1% w/v solution of (+)-tartaric acid for 30  minutes, centrifuge and use the supernatant liquid. Carry out the Assay described under Ergometrine Injection, beginning at the words 'To 3  ml...'.

Storage

Ergometrine Tablets should be protected from light.

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