Determination of ergometrine maleate and methylergometrine maleate in pharmaceutical preparations by high-performance liquid chromatography.

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Abstract
A high-performance liquid chromatographic method for the determination of ergometrine maleate (EM) and methylergometrine maleate (MM) [uterine stimulants] in pharmaceutical preparations was established. EM and MM were extracted with dichloromethane from injections and tablets in the presence of NaCl and ammonia solution. After evaporation of the dichloromethane, the residue was dissolved in water. Then EM and MM were determined by high-performance liquid chromatography [HPLC] on a LiChrosorb RP-18 column using a mixture of acetonitrile and 50 mM acetate buffer (pH 3.5) containing 1.5 mM triethylamine. In comparing the analytical data obtained by this method with those by the colorimetric method, both data were in excellent agreement except in the case of MM tables, which contained related compounds. EM in the solution prepared according to the content uniformity test for EM tablets in JP [Japanese Pharmacopoeia] X was determined by both methods. The average values of the contents in 10 tablets were 96.0% by the colorimetric method and 80.8% by the HPLC method. The degradation of EM took place during shaking for the extraction of EM and could not be detected by the colorimetric method.

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