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Analysis methods for various active components in oral contraceptive piacebo tablets
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A technology of active ingredients and analysis methods, applied in the field of analysis, can solve the problems of simultaneous detection of active ingredients, etc., and achieve the effect of simple testing and low cost
Active Publication Date: 2019-07-26
NOVAST LABORATORIES (CHINA) LTD
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This method cannot realize simultaneous detection of two or more active ingredients, and multiple inspections are required for contraceptive products containing different active ingredients
In addition, we did not find a method for the detection of multiple active hormone components in placebo tablets containing oral contraceptives reported in the literature. Therefore, a general analytical method was developed to quickly and easily analyze whether placebo tablets containing oral contraceptives contain multiple active hormones. hormonal components, with practical significance
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Embodiment 1
[0032] Determination of whether multiple active ingredients are contained in oral contraceptive blank tablets:
[0033] The tablet shall not contain the active ingredients of oral contraceptives: norgestimate, levonorgestrel, norethindrone acetate, norethindrone and ethinyl estradiol.
[0044] Preparation of mobile phase A (volume ratio of acetonitrile to water is 22:78):
[0045] Measure 440 ml of acetonitrile and 1560 ml of water in a measuring bottle, shake well.
[0046] Preparation of m...
Embodiment 2
[0058] Determination of whether multiple active ingredients are contained in oral contraceptive blank tablets:
[0059] The tablet shall not contain the active ingredients of oral contraceptives: norgestimate, levonorgestrel, norgestimate, norethindrone acetate, norethindrone, drospirenone, desogestrel and ethinyl estradiol.
[0070] Preparation of mobile phase A (volume ratio of acetonitrile to water is 22:78):
[0071] Measure 220 ml of acetonitrile and 780 ml of water in a measuring bottle, ...
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Abstract
The invention discloses analysis methods for various active components in oral contraceptive piacebo tablets. To-be-measured piacebo tablets are placed in a measuring flask; water is added to disintegrate the tablets; an organic solvent (acetonitrile) is added and ultrasonic extraction is carried out; volume is fixed to a scale through utilization of the acetonitrile; filtering is carried out; filtrate is taken as a test sample for analysis; the test sample is analyzed through adoption of a liquid chromatography; a chromatography collection computer system is started for collection of data; norethisterone acetate, desogestrel and ethinyloestradiol reference substances are obtained; a mixed solution of the acetonitrile and the water is used for preparing a reference substance solution; andthe liquid chromatography is carried out, so whether the piacebo tablets comprise various active components or not is measured. The method has the advantages of high specificity, rapid analysis and high anti-interference performance. The problem that the various active components in the oral contraceptive piacebo tablets need to be measured repeatedly is solved.
Description
technical field [0001] The invention specifically relates to an analysis method for quickly and conveniently determining whether the oral contraceptive placebo tablet contains multiple active ingredients. Background technique [0002] Oral contraceptive placebo tablets are preparations that do not contain any pharmacological ingredients, and have the effect of replacing and comforting people who take oral contraceptives for a long time. Manufacturers of contraceptive pills usually use generic contraceptive placebo tablets for different contraceptive products, and whether the placebo pills contain the corresponding active ingredients is an important part of their quality standards. For the determination of whether the placebo tablet contains active ingredients, the content determination method of each oral contraceptive is generally used at present. When progesterone tablets and desogestrel ethinylestradiol tablets were used, the content determination methods of norgestimate...
Claims
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