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Method for detecting lincomycin impurity E in lincomycin hydrochloride injection by high performance liquid chromatography-evaporative light method

A high-performance liquid chromatography, lincomycin hydrochloride technology, which is applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of inability to accurately identify and detect impurity E, quantitative detection, and inability to characterize lincomycin impurity E.

Active Publication Date: 2021-06-08
石药银湖制药有限公司
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Problems solved by technology

At present, the latest 2020 edition of "Chinese Pharmacopoeia" uses high-performance liquid chromatography ultraviolet detection method to detect the related substances of lincomycin hydrochloride injection. The method of "Chinese Pharmacopoeia" is used to detect lincomycin impurity E, and the resolution is poor. Lincomycin impurity E cannot be completely separated from the chromatographic peaks of other impurities, cannot accurately identify and detect impurity E, cannot clearly define the limit of impurity E, and cannot accurately perform qualitative and quantitative detection of lincomycin impurity E, so it cannot be comprehensively Guarantee product quality

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  • Method for detecting lincomycin impurity E in lincomycin hydrochloride injection by high performance liquid chromatography-evaporative light method
  • Method for detecting lincomycin impurity E in lincomycin hydrochloride injection by high performance liquid chromatography-evaporative light method
  • Method for detecting lincomycin impurity E in lincomycin hydrochloride injection by high performance liquid chromatography-evaporative light method

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Embodiment 1

[0037] The detection method of the present invention is used to detect lincomycin impurity E in lincomycin hydrochloride injection, wherein the chromatographic conditions for detection are evaporative light scattering detector drift tube temperature 50°C; carrier gas flow rate is 1.5L / min; The temperature is 30°C; the flow rate is 0.9ml / min.

[0038] The detection data of each concentration gradient of lincomycin impurity E standard substance are shown in Table 1:

[0039] Table 1 Detection data of each concentration gradient of lincomycin impurity E standard

[0040]

[0041]

[0042] Wherein, the chromatogram of lincomycin impurity E standard substance 2 is as follows figure 1 As shown, the chromatograms of the first group of sample solutions to be tested are as follows figure 2 shown.

[0043] Draw the standard curve of lincomycin impurity E standard substance according to the detection data such as the concentration of above-mentioned standard substance and peak ...

Embodiment 2

[0052] The detection method of the present invention is used to detect lincomycin impurity E in lincomycin hydrochloride injection, wherein the chromatographic conditions for detection are evaporative light scattering detector drift tube temperature 60°C; carrier gas flow rate is 2.2L / min; The temperature is 35°C; the flow rate is 1.2ml / min.

[0053] In the second group of sample solution to be tested, the chromatogram of lincomycin impurity E is as follows Figure 4 shown.

[0054] Using the chromatographic conditions in this example, the detected lincomycin impurity E had a peak eluting time of 7.794 minutes and a resolution of 25.58. This method can still qualitatively and quantitatively detect lincomycin impurity E.

Embodiment 3

[0056] The lincomycin impurity E standard substance and the third group of sample solutions to be tested were detected by using the high-performance liquid chromatography ultraviolet detection method recorded in the prior art "Chinese Pharmacopoeia".

[0057] Wherein, the chromatographic conditions for the ultraviolet detection of the high-performance liquid chromatograph are as follows: the detection wavelength is 214nm; the column temperature is 30°C; and the flow rate is 0.5ml / min.

[0058] The chromatogram of the lincomycin impurity E standard substance detected by high performance liquid chromatography is as follows Figure 5 As shown, the chromatograms of the third group of sample solutions to be tested are as follows Figure 6 shown.

[0059] In the present embodiment, the chromatogram of lincomycin impurity E standard Figure 5 It shows that its peak time is 9.581min, which leads to the chromatogram of the third group of sample solutions to be tested. Figure 6 Amon...

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Abstract

The invention relates to a method for detecting lincomycin impurity E in lincomycin hydrochloride injection by high performance liquid chromatography-evaporative light method. According to the method, a mobile phase A is a trifluoroacetic acid solution with the mass fraction of 0.05%, and a mobile phase B is a methanol solution; the volume ratio of the two is 80:20; and according to the method, accurate qualitative and quantitative detection of the lincomycin impurity E can be realized, and an effective and reliable detection means is provided for product detection of lincomycin hydrochloride injection.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for detecting lincomycin impurity E in lincomycin hydrochloride injection by high performance liquid chromatography-evaporative light method. Background technique [0002] Lincomycin hydrochloride is commonly used in tablets, capsules, eye drops, ear drops, injections, ointments, etc. As a bacteriostatic drug, it is used for respiratory tract infection, skin and soft tissue infection, female reproductive tract infection, pelvic infection and abdominal infection caused by sensitive Staphylococcus, Streptococcus, Streptococcus pneumoniae and anaerobic bacteria. [0003] In lincomycin hydrochloride injection, the following impurities may exist: [0004] Lincomycin impurity E, chemical name: (2s,4r)-1-methyl-4-propylpyrrolidine-2-carboxylic acid, structural formula: [0005] [0006] Lincomycin impurity E is a degradation impurity that is sensitive to temperat...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74G01N30/88
CPCG01N30/06G01N30/74G01N30/88
Inventor 王金梅张继勇王艳周狄彩霞郭良姚春虎高凯丽赵青董晓花李曼邵梦超
Owner 石药银湖制药有限公司
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