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A kind of detection method of polymer in terlipressin for injection

A high-molecular polymer and terlipressin technology, which is applied to the detection of high-molecular polymers in terlipressin for injection, and in the field of terlipressin for injection, can solve the problem of unsuitable high-molecular polymer detection, etc. problem, to achieve the effect of simple method, guaranteed accuracy and strong operability

Active Publication Date: 2021-12-10
CHINA MEHECO SANYANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the prior art, there is no detection method for polymers in terlipressin for injection, and the existing detection method for the content of related substances in terlipressin for injection is a high-performance liquid chromatography detection method, such as the patent A method for analyzing related substances of terlipressin for injection disclosed in the document CN105301156A, its chromatographic conditions select octadecyl resin column, its mobile phase adopts sodium dihydrogen phosphate-acetonitrile mobile phase, and usually the reference solution and the supplied The test samples are tested by chromatography separately, and because the related substances are some small molecular substances, it is not suitable for the detection of high molecular polymers.

Method used

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  • A kind of detection method of polymer in terlipressin for injection
  • A kind of detection method of polymer in terlipressin for injection
  • A kind of detection method of polymer in terlipressin for injection

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preparation example Construction

[0046] The preparation process of the terlipressin for injection is to fully mix a predetermined amount of terlipressin acetate, mannitol and hydrochloric acid, and then carry out gradient freeze-drying.

[0047] The detection method of high-molecular polymer in terlipressin for injection is to utilize high-performance liquid chromatography, and the chromatographic conditions of this high-performance liquid chromatography are as follows:

[0048] Chromatographic column: TSKgel G2000SWXL, size 7.8mm×300mm, 5um;

[0049] Mobile phase: prepare 0.1mol / L sodium sulfate solution with 0.1mol / L phosphate buffer; the phosphate buffer is composed of 0.0565mol / L disodium hydrogen phosphate and 0.0435mol / L sodium dihydrogen phosphate; sodium sulfate The pH value of the solution is 6.5-6.9.

[0050] Detection wavelength: 274nm;

[0051] Flow rate: 0.5ml / min;

[0052] Column temperature: 25°C;

[0053] Injection volume: 20μl

[0054] Elution method: isocratic elution.

[0055] Above-m...

Embodiment 1

[0062] A detection method for polymers in terlipressin for injection, the detection method is to utilize high performance liquid chromatography, and the chromatographic conditions of the high performance liquid chromatography are as follows:

[0063] Chromatographic column: TSKgel G2000SWXL, size 7.8mm×300mm, 5um;

[0064] Mobile phase: prepare 0.1mol / L sodium sulfate solution with 0.1mol / L phosphate buffer; the phosphate buffer is composed of equal volumes of 0.0565mol / L disodium hydrogen phosphate and 0.0435mol / L sodium dihydrogen phosphate; The pH of the sodium sulfate solution is 6.7.

[0065] Detection wavelength: 274nm;

[0066] Flow rate: 0.5ml / min;

[0067] Column temperature: 25°C;

[0068] Injection volume: 20μl;

[0069] Elution method: isocratic elution.

[0070] Above-mentioned detection method comprises following detection steps:

[0071] S1: Take the mobile phase of terlipressin for injection and configure it into a test solution with a concentration of te...

Embodiment 2

[0093] Embodiment 2 is identical with embodiment 1 chromatographic conditions, and system suitability test, blank detection and blank auxiliary material detection are also identical, and difference is that reference substance solution is different from test sample solution batches, and its contrast solution chromatogram and test sample solution The chromatograms are as Figure 5 As shown in the upper and lower parts, the peak tables are as follows:

[0094] serial number keep time Peak area Peak height Relative peak area % Number of plates (EP) Asymmetry (EP) Resolution (EP) 1 22.471 0.398 1.284 100.000 36474 1.13 n.a sum 0.398 1.284 100.000 36474.00 1.13 serial number keep time Peak area Peak height Relative peak area % Number of plates (EP) Asymmetry (EP) Resolution (EP) 1 22.456 39.439 124.304 100.000 35458 1.19 n.a sum 39.439 124.304 100.000 35458.00 1.19

[0095] According t...

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Abstract

The invention discloses a method for detecting and analyzing high-molecular polymers in terlipressin for injection, which belongs to the technical field of compound detection and analysis. As follows: Chromatographic column: TSKgel G2000SWXL, size 7.8mm×300mm, 5um; mobile phase: 0.1mol / L sodium sulfate solution prepared with 0.1mol / L phosphate buffer; detection wavelength: 274nm; flow rate: 0.5ml / min; Temperature: 25°C; Injection volume: 20μl; Elution method: Isocratic elution. The invention can accurately detect the content of high molecular polymer in the terlipressin for injection, can effectively control the content of high molecular polymer in the product, and the detection method of the invention has the advantages of simple method and strong operability.

Description

technical field [0001] The invention relates to terlipressin for injection, in particular to a method for detecting polymers in terlipressin for injection, and belongs to the technical field of compound detection and analysis. Background technique [0002] Terlipressin (Terlipressin) chemical name N-α-triglycyl-8-lysine-vasopressin, white powder, molecular formula C 52 h 74 N 16 o 15 S 2 , the molecular weight is 1227.37000, and the density is 1.46g / cm 3 . The main active ingredient of terlipressin for injection is terlipressin (triglycine-8-lysine-vasopressin), which is a chemically synthesized polypeptide compound. The pharmacological effects of terlipressin are: reduce portal hypertension, reduce blood flow in the portal vein area, contract esophageal smooth muscle, and continuously compress esophageal varices. Terlipressin for injection is mainly used for the treatment of bleeding from esophageal varices. [0003] Terlipressin for injection is terlipressin in mol...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/885
Inventor 李富志张洁章世舜程云峰朱峰王玉娟
Owner CHINA MEHECO SANYANG PHARMA CO LTD
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