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Method for analyzing related substances of pidotimod oral solution

A technology for related substances and oral solutions, which is applied in the field of determination of drug-related substances, can solve the problems of low detection ability, insufficient control of impurities, low proportion of organic phase, etc., and achieve good repeatability, strong specificity and high accuracy. Effect

Active Publication Date: 2021-07-02
ANHUI WANBANG MEDICAL TECH
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  • Description
  • Claims
  • Application Information

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Problems solved by technology

The pharmacopoeias of various countries have not recorded the detection methods of related substances in pidotimod oral solution. After inquiring, the registration standard of pidotimod raw materials (YBH08282006) was obtained, and the detection method was reproduced. Due to the proportion of the organic phase (methanol) in the chromatographic conditions Low; therefore the detection ability is not high, and the control of impurities is not strict enough

Method used

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  • Method for analyzing related substances of pidotimod oral solution
  • Method for analyzing related substances of pidotimod oral solution
  • Method for analyzing related substances of pidotimod oral solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] In this example, the solution containing pidotimod is taken as an example, and the methodological validation of the chromatographic method is used.

[0022] 1. Related substance location test

[0023] Prepare the sample solution of pidotimod, the control solution of each related substance, and the mixed solution of pidotimod and each related substance, inject them into the liquid chromatograph respectively, and record the chromatogram. The results are shown in Table 1, and the spectrum is shown in figure 1 .

[0024] Table 1 Pidotimod and the results of the separation parameters of each impurity

[0025] Impurity name Individual injection retention time Mixed injection retention time relative retention time Separation from front peak L-pyroglutamic acid 6.435 5.805 0.40 / Impurity A 13.719 12.948 0.89 17.844 Pidotimod 14.660 14.517 1.00 3.802 Impurity C 16.396 16.246 1.12 3.538 Impurity E 16.177 16.246 1.12...

Embodiment 2

[0048] In this embodiment, six batches of pidotimod oral solution pilot drug were taken as an example to determine related substances.

[0049] Accurately measure 1ml each of 6 batches of pidotimod oral solution, place them in 100ml measuring bottles respectively, and use pH6.8 phosphate buffer (take 1.3g of potassium dihydrogen phosphate, 1.55g of disodium hydrogen phosphate (anhydrous substance) , dissolved in water and diluted to 1000ml, adjusted to pH 6.80 with phosphoric acid) diluted to the mark, shaken up to obtain the test solution; take pidotimod reference substance, L-pyroglutamic acid reference substance, impurity X reference substance and impurity An appropriate amount of each Y reference substance was dissolved and diluted with pH 6.8 phosphate buffer to make a solution containing about 2.5 μg of each impurity per 1 ml to obtain a reference substance solution.

[0050]Chromatographic conditions: use Shimadzu high-performance liquid chromatography, ultraviolet dete...

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Abstract

The invention discloses a method for analyzing related substances of a pidotimod oral solution, which adopts a high performance liquid chromatography, takes octadecylsilane chemically bonded silica as a chromatographic column filler, adopts an ultraviolet detector, selects a proper organic solvent and a buffer solution as mobile phases, and performs gradient elution to effectively complete separation of pidotimod and related impurities thereof. The method has the advantages of strong specificity, good repeatability and high accuracy, and can ensure the controllability of pidotimod related substances.

Description

technical field [0001] The invention relates to the technical field of determination of related substances of medicines, in particular to a method for analyzing related substances of pidotimod oral solution. Background technique [0002] Related substances are closely related to the quality, safety and curative effect of drugs. The existence of related substances may reduce the curative effect of drugs and even cause toxic and side effects. Therefore, appropriate detection and analysis methods must be used to control the type and content of related substances in drugs to ensure quality. [0003] Pidotimod is a commonly used immunostimulant, chemical name: (R)-3-[(s)-(5-oxo-2-pyrrolidinyl-)carbonyl]-tetrahydrothiazole-4-carboxylic acid . Pharmacopoeias of various countries have not recorded the detection methods of related substances in pidotimod oral solution. After inquiring, the registration standard of pidotimod raw materials (YBH08282006) was obtained, and the detectio...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 李逍陶春蕾孟广东李杰
Owner ANHUI WANBANG MEDICAL TECH
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