Abstract
A rapid, sensitive, and accurate GLC method of analysis of a new estrogenic drug, 17α‐ethynylestriol 3‐cyclopentyl ether, was developed. The drug and the internal standard, tetratri‐acontane, are dissolved in chloroform, and an aliquot is heated with N‐trimethylsilylimidazole at 80° for 30min. The silylated sample is chromatographed using a column packed with 1% methyl vinyl silicone gum on Gas Chrom Q. Quantitation is achieved by computer calculation of the peak area ratios. The observed peak is the 16α, 17β‐bistrimethylsilyl derivative of the new drug substance. The GLC method was applied to the quantitative determination of the estrogenic compound in a tablet formulation containing 25 μg/tablet.
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