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Method for determining content of glyceryl monostearate and glyceryl distearate in promestriene cream

A technology of glyceryl distearate and prostalene cream, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of measurement interference, inability to accurately quantify the content of glyceryl distearate, and avoid the Interference, good specificity and accuracy, good peak shape

Pending Publication Date: 2022-03-08
BEIJING JINCHENG TAIER PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] According to the four methods of the Chinese Pharmacopoeia 2020 edition, the content of glyceryl monostearate in proestrel cream was determined. Other excipients in proestrel cream interfered greatly with the determination, and could not determine the content of monoglyceride and stearate in the reference preparation. Accurate quantification of glyceryl stearate content

Method used

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  • Method for determining content of glyceryl monostearate and glyceryl distearate in promestriene cream
  • Method for determining content of glyceryl monostearate and glyceryl distearate in promestriene cream
  • Method for determining content of glyceryl monostearate and glyceryl distearate in promestriene cream

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Experimental program
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Embodiment 1

[0042] 1. Instruments and Reagents

[0043] 1.1 Instrument

[0044] Liquid chromatograph, 100,000-level electronic balance; constant temperature heater

[0045] 1.2 Reagents

[0046] Methanol, acetonitrile, tetrahydrofuran, water, trifluoroacetic acid

[0047] 1.3 Reference substance and test substance

[0048] Glyceryl Monodistearate; Promestriene Cream

[0049] 2. Chromatographic conditions

[0050] Chromatographic column: a chromatographic column with octadecylsilane bonded silica gel as filler (or similar in polarity).

[0051] Run gradient:

[0052]

[0053] Wherein: mobile phase A is methanol, mobile phase B is acetonitrile, and mobile phase C is an aqueous solution of tetrahydrofuran containing trifluoroacetic acid; the volume content of tetrahydrofuran in mobile phase C is 20%, and the volume content of trifluoroacetic acid is 0.01%.

[0054] 3. Experimental process

[0055] 3.1 Solvent: methanol-acetonitrile (volume ratio 1:1).

[0056] 3.2 Preparation of ...

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Abstract

The invention belongs to the technical field of substance detection, and particularly relates to a method for determining the content of glyceryl monostearate and glyceryl distearate in promestriene cream. The blank solution, the test sample solution and the reference substance solution are taken and injected into a liquid chromatograph for detection, a chromatogram is recorded, and the test sample solution is prepared according to the following steps that methyl alcohol and acetonitrile are added into the promestriene cream, heating and dissolving are conducted, then methyl alcohol and acetonitrile are used for dilution, and the test sample solution is obtained. According to the method disclosed by the invention, by selecting the mobile phase and controlling the running gradient, the peak pattern of the glyceryl monostearate and the glyceryl distearate in the HPLC spectrum is good, the number of theoretical plates and the response value are high, the separation degree among the peaks meets the specification, and the accuracy meets the quantitative detection requirement. Meanwhile, the interference of other components in the promestriene cream on the determination of glyceryl monostearate and glyceryl distearate is avoided, and the method has good specificity and accuracy.

Description

technical field [0001] The invention belongs to the technical field of substance detection, and in particular relates to a method for determining the content of glyceryl monostearate in promestriene cream. Background technique [0002] Glyceryl mono and distearate is the most widely used additive and emulsifier in the oleochemical and daily chemical industries. In cream preparations, as an emulsifier, it is one of the important prescription components. When researching cream formulations, if the ratio of monoglycerides and distearates in the reference formulation can be accurately analyzed, the difficulty of formulation screening can be reduced. [0003] Chinese patent CN103575815A discloses a method for detecting glyceryl monostearate in liquid milk, comprising: a. taking liquid milk to be tested, extracting milk fat therein to obtain milk fat to be tested; b. preparing glyceryl monostearate standard solution, and dry the standard solution with nitrogen to prepare the sta...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 安勇向宏艳王立茹孟庆博李泉志段月晓刘洪亮黄海玉高银辉韦国荣
Owner BEIJING JINCHENG TAIER PHARMA CO LTD
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