- British Pharmacopoeia Volume III
- Formulated Preparations: Specific Monographs
Ergometrine Tablets contain Ergometrine Maleate.
The tablets comply with the requirements stated under Tablets and with the following requirements.
90.0 to 110.0% of the stated amount.
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.
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.
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...'.
Ergometrine Tablets should be protected from light.
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