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复方炔诺酮每片含炔诺酮0.6mg,炔雌醇0.035mg,中国药典1977年版已收载。炔雌醇因含量极微,故未规定含量测定。但是炔雌醇含量是关系到该制剂质量的一个重要指标,並影响到临床用药的安全与有效。为此试用微分光谱法对复方炔诺酮片中炔雌醇含量进行了测定。炔诺酮、炔雌醇在270～350nm的吸收光谱虽互相重迭,但其微分光谱互不影响。炔雌醇在288～294nm波长处的吸收度差值较大,并与其浓度呈良好的线性关系,而炔诺酮在此波长处的微分光谱是平直的。无水乙醇、片剂辅料及空白片芯的微分光谱也是平直的,所以用无水乙醇作溶剂对测定无影响。未经过滤片剂的无水乙醇液在放置不同时间或过滤后测定几乎对微分吸收度差值无影响,因此样品可以不过滤直接测定。微分条件采用狭缝2.0nm,扫描速度300nm/秒,
Compound norethisterone containing norethindrone 0.6mg, ethinyl estradiol 0.035mg, Chinese Pharmacopoeia 1977 edition has been included. Ethinyl estradiol because of the content is minimal, it is not required to determine the content. However, the content of ethinylestradiol is an important index that relates to the quality of the preparation, and affects the safety and effectiveness of clinical medication. For this reason, differential spectrometry was used to determine the content of ethinyl estradiol in compound norgestione tablets. Norethindrone, ethinylestradiol in the 270 ~ 350nm absorption spectra overlap, but its differential spectra do not affect each other. Ethinylestradiol showed a large difference in absorbance at a wavelength of 288 nm to 294 nm and showed a good linear relationship with its concentration, whereas the derivative spectrum of norethindrone at this wavelength was flat. Differential spectroscopy of anhydrous ethanol, tablet excipients and blank cores is also flat, so no effect on the assay with absolute ethanol as a solvent. Unlaminated absolute ethanol solution at different times or after filtration has almost no effect on the difference in differential absorbance, so the sample can be measured directly without filtration. The differential conditions adopted a slit of 2.0 nm, a scanning speed of 300 nm / second,