An analytical method for multiple active ingredients in oral contraceptive placebo tablets

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: 2021-12-21
NOVAST LABORATORIES (CHINA) LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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

Method used

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  • An analytical method for multiple active ingredients in oral contraceptive placebo tablets
  • An analytical method for multiple active ingredients in oral contraceptive placebo tablets
  • An analytical method for multiple active ingredients in oral contraceptive placebo tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Determination of whether multiple active ingredients are contained in oral contraceptive blank tablets:

[0031] The tablet shall not contain the active ingredients of oral contraceptives: norgestimate, levonorgestrel, norethindrone acetate, norethindrone and ethinyl estradiol.

[0032] (1) Instruments and conditions

[0033] Liquid chromatograph: high performance liquid chromatography system and workstation;

[0034] Chromatographic column: Octadecylsilane bonded silica gel as filler, column length 150mm, inner diameter 4.6mm, particle size 5mm;

[0035] Detection wavelength: 210nm and 245nm

[0036] Injection volume: 50µL

[0037] Column temperature: 40°C

[0038] Analysis time: 18 minutes

[0039] gradient:

[0040]

[0041] (2), experimental steps

[0042] Preparation of mobile phase A (volume ratio of acetonitrile to water is 22:78):

[0043] Measure 440 ml of acetonitrile and 1560 ml of water in a measuring bottle, shake well.

[0044] Preparation of m...

Embodiment 2

[0056] Determination of whether multiple active ingredients are contained in oral contraceptive blank tablets:

[0057] The tablet shall not contain the active ingredients of oral contraceptives: norgestimate, levonorgestrel, norgestimate, norethindrone acetate, norethindrone, drospirenone, desogestrel and ethinyl estradiol.

[0058] (1) Instruments and conditions

[0059] Liquid chromatograph: high performance liquid chromatography system and workstation;

[0060] Chromatographic column: Octadecylsilane bonded silica gel as filler, column length 150mm, inner diameter 4.6mm, particle size 5mm;

[0061]Detection wavelength: 210nm and 245nm

[0062] Injection volume: 50µL

[0063] Column temperature: 40°C

[0064] Analysis time: 18 minutes

[0065] gradient:

[0066]

[0067] (2), experimental steps

[0068] Preparation of mobile phase A (volume ratio of acetonitrile to water is 22:78):

[0069] Measure 220 ml of acetonitrile and 780 ml of water in a measuring bottle,...

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Abstract

The invention discloses an analysis method for various active ingredients in oral contraceptive pill placebo tablets. Firstly, put the placebo tablet to be tested into a measuring bottle, then add water to make it disintegrate, and then add an organic solvent (acetonitrile) for ultrasonic extraction. Then use acetonitrile to set the volume to scale, filter and get the filtrate as the test sample analysis; adopt liquid chromatography to analyze the test sample, start the chromatographic acquisition computer system to collect data; get norethindrone acetate, desogestrel and ethinyl estradiol contrast For the product, prepare the reference solution with a mixed solution of acetonitrile and water, and carry out liquid chromatography analysis simultaneously to check whether the placebo tablet contains multiple active ingredients. The invention has the advantages of strong specificity, rapid analysis, strong anti-interference and high sensitivity, and solves the problem that multiple active ingredients in oral contraceptive placebo tablets need to be repeatedly measured.

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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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 姚海燕金霞谢卫红郑晓菊柴冬梅施瑞尼张国华
Owner NOVAST LABORATORIES (CHINA) LTD
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