A kind of impurity detection and analysis method of norethindrone derivative and its intermediate

An analytical method and intermediate technology are applied in the field of impurity analysis of steroid compounds to achieve the effects of improving detection efficiency and shortening detection time.
CN105277633BActive Publication Date: 2017-06-23ZHEJIANG XIANJU PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
ZHEJIANG XIANJU PHARMA
Publication Date
2017-06-23

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Abstract

The present invention relates to a method for analyzing impurities of steroidal compounds, in particular to a method for detecting and analyzing impurities of norethindrone derivatives and their intermediates, comprising: (1) choosing octadecylsilane bonded silica gel as filler The chromatographic column; the gradient elution of the mobile phase, the composition of the mobile phase is water, methanol and acetonitrile; the detection wavelength is 230 ~ 254nm; (2) take the test sample norethindrone derivative or its intermediate amount, accurately weigh the methanol Dissolve and dilute to a certain concentration of the sample solution, shake it up, inject the sample, perform high-performance liquid chromatography analysis at an appropriate flow rate and column temperature, and record the chromatogram. The invention can quickly and accurately realize the impurity analysis of norethindrone derivatives, especially for the impurity analysis of norethindrone enanthate, and can be used for the impurity analysis of norethindrone derivative intermediates, and can effectively track the impurities produced in the synthesis process. Impurities.
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Description

technical field

[0001] The invention relates to a method for analyzing impurities of steroidal compounds, in particular to a method for detecting and analyzing impurities of norethindrone derivatives and intermediates thereof. Background technique

[0002] Norethindrone drugs are a class of progestogens that can be used to treat premenstrual syndrome, dysmenorrhea, excessive menstrual bleeding, abnormal menstruation, and menopausal syndrome. They are also commonly used as oral short-acting contraceptives. Norethindrone is the first oral high-efficiency progestogen that can be synthesized, and its esterified derivatives have the same pharmacological effects, but also prolong the time of action. Common norethindrone esterified derivatives include norethindrone acetate, norethindrone caproate, norethindrone enanthate, norethindrone octanoate, etc., wherein norethindrone enanthate and estradiol valerate compound injection Effective contraceptives can continue to prevent pregnan...

Claims

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