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Detection method of enoxaparin sodium

A technology of enoxaparin sodium and detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of inconvenient, complex procedures, separation effect, and inability to directly reflect the stability of product quality and production process, and achieve detection The method is simple and accurate to detect the effect of

Active Publication Date: 2016-06-01
中关村科技租赁股份有限公司
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Problems solved by technology

[0004] However, the existing detection methods of enoxaparin sodium: Chinese patents CN102323355A and CN104193849A, when detecting enoxaparin sodium, more than 10 chromatographic peaks need to be detected at the same time to evaluate the product quality of enoxaparin sodium, and the detection results cannot be intuitive It reflects the quality of the product and / or the stability of its production process, and it also needs to use gradient elution with complex procedures but good separation effect, which is not easy

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  • Detection method of enoxaparin sodium
  • Detection method of enoxaparin sodium
  • Detection method of enoxaparin sodium

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Embodiment 1

[0032] The raw materials and equipment used in the specific embodiment of the present invention are all known products, obtained by purchasing commercially available products. Embodiment 1. The present invention detects the method for the ratio of glucosamine and mannosamine in enoxaparin sodium

[0033] 1. Instruments and reagents

[0034] ZORBAXEclipseXDB-C18 column (4.6 × 150mm, the United States, Agilent Company); high performance liquid chromatography (Agilent-1260, the United States Agilent Company), equipped with UV detector and data analysis software;

[0035] Enoxaparin sodium sample (Chengdu Baiyu Pharmaceutical Co., Ltd., batch 110401);

[0036] Standard Enoxaparin Sodium (EP, E0180000);

[0037] Glucosamine standard products, glucuronic acid standard products, galactosamine standard products, galacturonic acid standard products, and 1-phenyl-3-methyl-5-pyrazolone (PMP) were all purchased from Sigma, USA ;

[0038] Acetonitrile is HPLC grade reagent;

[0039] T...

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Abstract

The invention discloses a detection method of enoxaparin sodium. The detection method of the enoxaparin sodium comprises the following steps of a, taking anenoxaparin sodium sample, and carrying out hydrolysis to obtain a hydrolysis solution; b, taking the hydrolysis solution, and carrying out derivatization to obtain a solution to be detected; c, adopting a high performance liquid chromatography method to detect the solution to be detected, detecting to obtain a peak area of glucosamine and mannosamine, and calculating to obtain the proportion of the glucosamine and the mannosamine. According to the detection method provided by the invention, the proportion of the glucosamine and the mannosamine is detected, so that the product quality and / or the stability of the production process can be reflected intuitively; in addition, the detection method is simple and convenient, does not need to adopt a complicated gradient elution program so as to realize accurate detection on the enoxaparin sodium, and provides a novel simple and practical method for monitoring the product quality and / or the stability of the production process of the enoxaparin sodium.

Description

technical field [0001] The invention relates to a method for detecting enoxaparin sodium. Background technique [0002] Enoxaparin sodium, as an anticoagulant used for the prevention and treatment of deep vein thrombosis or pulmonary embolism, its product quality is directly related to the life safety of patients. [0003] In the production process of enoxaparin sodium, if the production technology of the enterprise is not advanced or the control level is not high, the quality of its products is likely to fluctuate greatly; therefore, in order to monitor the product quality of enoxaparin sodium and / or The stability of its production process, and at the same time, in order to minimize the economic loss caused by product quality fluctuations, it is necessary to detect the produced enoxaparin sodium. [0004] However, the existing detection methods of enoxaparin sodium: Chinese patents CN102323355A and CN104193849A, when detecting enoxaparin sodium, more than 10 chromatographi...

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Application Information

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IPC IPC(8): G01N30/89G01N30/06
CPCG01N30/06G01N30/89
Inventor 何捷
Owner 中关村科技租赁股份有限公司
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