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      • Oral Contraceptives 中 Progestogen의 分析에 관한 硏究

        沈英燮,李信良 成均館大學校 科學技術硏究所 1984 論文集 Vol.35 No.1

        Norgestrel (13-Ethyl-l7-hydroxy-18, 19-diner-17α-pregn-4-en-20-yn-3-one) is a potent progestrone type contraceptive and presently gaining wide acceptance in therapeutic practice. Ethinyl estradiol (19-Nor-l7-pregna-1, 3, 5, 10-trim-20-yne-3, 17-diol) is a potent oestrogenic compound. It is either prescribed singly in the form of tablets or in the mixtures with progestational steroids in oral contraceptive formulations. In all cases it is prescribed in such low dosage level as to necessitate the availability of sensitive techniques for its evaluation. The analysis of progestogen and oestrogen steroids in oral contraceptive dosage form has spanned over almost two decades. Analytical methods for the progestogens have utilized ultraviolet spectrophotometric and colorimetric techniques. Recently a number of gas liquid chromatographic methods and fluorometric techniques were utilized for the oestrogen assay. The main drawback in the case of ultraviolet and colorimetric procedures appears to be the lack of specificity in the presence of other steroids. On the other hand, thermal decomposition of the oestrogen have been reported as a limiting factor for the method utilizing gas-liquid chromatography. In the last few years when the rapid advances of high performance liquid chromatography(HPLC) have been accomplished, many papers have been published on the analysis and separation of steroids. This paper describes the use of HPLC system for the simultaneous analysis of both steroids, norgestrel and ethinyl estradiol. The analytical procedures outlined in this paper afford a specific, quick, and accurate assay by reverse phase high performance liquid chromatography Yor the two steroids, commonly used in oral contraceptive preparation. The best resolution between NG and EE was achieved with a solvent system of acetonitrile/water (60 : 40). The two steroids were separated easily using the 254nm and 280nm filter simultaneously. Prednisolone was found to be the most suitable as internal standard to prevent from possible inter fering peaks and impurities.

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