CN104215714A - Determination method of related substance of cefodizime sodium for injection - Google Patents
Determination method of related substance of cefodizime sodium for injection Download PDFInfo
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- CN104215714A CN104215714A CN201410481919.7A CN201410481919A CN104215714A CN 104215714 A CN104215714 A CN 104215714A CN 201410481919 A CN201410481919 A CN 201410481919A CN 104215714 A CN104215714 A CN 104215714A
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Abstract
The invention discloses a determination method of related substances of cefodizime sodium for injection. With an isocratic elution method and 220nm detection length, the end adsorption of cefodizime sodium for injection is reduced, the interference of base line noise can be reduced, the accuracy and the flexibility of detection are improved, the operation is simple and the method has practical value.
Description
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Technical field
The present invention relates to field of pharmaceutical biology, particularly, relate to the assay method of cefodizime sodium for injection related substance.
Background technology
Cefodizime Sodium is the semi-synthetic cynnematin of third generation wide spectrum of Hoest company and the cooperative development of Rusell company.Cefodizime Sodium has outside broad spectrum antibiotic activity, long-acting, also has the unexistent immunoregulatory activity of the semi-synthetic cynnematin of other third generations.This is mainly because Cefodizime Sodium contains 2-sulfydryl-this unique substituting group of 4-methyl-5-thiazole acetic acid.Be mainly used in the negative microbial upper lower urinary tract infection of staphylococcus, streptococcus and most of Ge Lan clinically, lower respiratory infection, gonorrhoea etc.
Impurity in medicine can have influence on the purity of product, and impurity level is too much easy to cause the allergic reaction of medication to cause medication to there is potential safety hazard, affect the stability of medicine, thus curative effect of medication is reduced, particularly Cefodizime Sodium is in production and storage process, easy generation Cefodizime Sodium related substance and Cefodizime sodium polymer, affect the stability of product.Therefore Cefodizime Sodium is purer, and clinical application more has security.Related substance in mensuration cefodizime sodium for injection is played an important role to safe medication, effective method must be set up to measure the content of the related substance in medicine to control the product quality in commercial production.
Summary of the invention
Technical matters to be solved by this invention is to provide the assay method of cefodizime sodium for injection related substance, the method adopts isocratic elution method, and adopt the detection length of 220nm to absorb with the end reducing Cefodizime Sodium, the interference of baseline noise can be reduced, improve the accuracy of detection, sensitivity, and simple to operate, there is practical value.
The present invention's adopted technical scheme that solves the problem is:
The assay method of cefodizime sodium for injection related substance, adopt isocratic elution high performance liquid chromatography, and select 220nm as determined wavelength, wherein with the phosphate buffer of the 0.1mol/L of pH7.0 for mobile phase A, take deionized water as Mobile phase B, respectively with A, B two kinds of mobile phase injecting chromatographs, then get 0.1mg/ml blue Dextran 200 0 solution injecting chromatograph, the retention time ratio at blue Dextran 200 0 peak of A, B mobile phase obtained is between 0.95-1.05.
The assay method of cefodizime sodium for injection related substance, specifically comprises the following steps:
(1) applicability is tested: by Mobile phase B injecting chromatograph, continuous sample introduction 5 times;
(2) set up linear equation, establish the sample size scope that the linear relationship of Cefodizime reference substance is good;
(3) reappearance experiment is set up: by mobile phase A injecting chromatograph, continuous sample introduction 5 times, obtains RSD%, if RSD% is less than 0.3%, then reappearance is good;
(4) sample determination: get testing sample 0.2g ± 0.001, is placed in 10ml volumetric flask, adds deionized water and is diluted to scale, closely measure sample introduction, and carries out mensuration such as degree such as grade with mobile phase A injecting chromatograph, and obtain result, wherein flow velocity is 1.0ml/min.
Described testing sample is stored in the refrigerator of 2-10 DEG C.
The sample introduction scope that the linear relationship of described Cefodizime reference substance is good is 5-25 microgram.
Described chromatographic filler is sephadex G-10.
To sum up, the invention has the beneficial effects as follows:
The present invention adopts isocratic elution method, and adopts the detection length of 220nm to absorb with the end reducing Cefodizime Sodium, can reduce the interference of baseline noise, improve the accuracy of detection, sensitivity, and simple to operate, has practical value.
Embodiment
Below in conjunction with embodiment, to the detailed description further of the present invention's do, but embodiments of the present invention are not limited thereto.
Embodiment 1:
The assay method of cefodizime sodium for injection related substance, adopt isocratic elution high performance liquid chromatography, and select 220nm as determined wavelength, wherein with the phosphate buffer of the 0.1mol/L of pH7.0 for mobile phase A, take deionized water as Mobile phase B, respectively with A, B two kinds of mobile phase injecting chromatographs, then get 0.1mg/ml blue Dextran 200 0 solution injecting chromatograph, the retention time ratio at blue Dextran 200 0 peak of A, B mobile phase obtained is between 0.95-1.05.
The assay method of cefodizime sodium for injection related substance, specifically comprises the following steps:
(1) applicability is tested: by Mobile phase B injecting chromatograph, continuous sample introduction 5 times;
(2) set up linear equation, establish the sample size scope that the linear relationship of Cefodizime reference substance is good;
(3) reappearance experiment is set up: by mobile phase A injecting chromatograph, continuous sample introduction 5 times, obtains RSD%, if RSD% is less than 0.3%, then reappearance is good;
(4) sample determination: get testing sample 0.2g ± 0.001, is placed in 10ml volumetric flask, adds deionized water and is diluted to scale, closely measure sample introduction, and carries out mensuration such as degree such as grade with mobile phase A injecting chromatograph, and obtain result, wherein flow velocity is 1.0ml/min.
Described testing sample is stored in the refrigerator of 2-10 DEG C.
The sample introduction scope that the linear relationship of described Cefodizime reference substance is good is 5-25 microgram.
Described chromatographic filler is sephadex G-10.
Claims (5)
1. the assay method of cefodizime sodium for injection related substance, it is characterized in that, adopt isocratic elution high performance liquid chromatography, and select 220nm as determined wavelength, wherein with the phosphate buffer of the 0.1mol/L of pH7.0 for mobile phase A, take deionized water as Mobile phase B, respectively with A, B two kinds of mobile phase injecting chromatographs, get 0.1mg/ml blue Dextran 200 0 solution injecting chromatograph again, the retention time ratio at blue Dextran 200 0 peak of A, B mobile phase obtained is between 0.95-1.05.
2. the assay method of cefodizime sodium for injection related substance according to claim 1, is characterized in that, specifically comprise the following steps:
(1) applicability is tested: by Mobile phase B injecting chromatograph, continuous sample introduction 5 times;
(2) set up linear equation, establish the sample size scope that the linear relationship of Cefodizime reference substance is good;
(3) reappearance experiment is set up: by mobile phase A injecting chromatograph, continuous sample introduction 5 times, obtains RSD%, if RSD% is less than 0.3%, then reappearance is good;
(4) sample determination: get testing sample 0.2g ± 0.001, is placed in 10ml volumetric flask, adds deionized water and is diluted to scale, closely measure sample introduction, and carries out mensuration such as degree such as grade with mobile phase A injecting chromatograph, and obtain result, wherein flow velocity is 1.0ml/min.
3. the assay method of cefodizime sodium for injection related substance according to claim 1, is characterized in that, described testing sample is stored in the refrigerator of 2-10 DEG C.
4. the assay method of cefodizime sodium for injection related substance according to claim 1, is characterized in that, the sample introduction scope that the linear relationship of described Cefodizime reference substance is good is 5-25 microgram.
5. the assay method of cefodizime sodium for injection related substance according to claim 1, is characterized in that, described chromatographic filler is sephadex G-10.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410481919.7A CN104215714A (en) | 2014-09-21 | 2014-09-21 | Determination method of related substance of cefodizime sodium for injection |
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| CN201410481919.7A CN104215714A (en) | 2014-09-21 | 2014-09-21 | Determination method of related substance of cefodizime sodium for injection |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105116076A (en) * | 2015-09-28 | 2015-12-02 | 苏州二叶制药有限公司 | Method for detecting cefodizime sodium related substances |
-
2014
- 2014-09-21 CN CN201410481919.7A patent/CN104215714A/en active Pending
Non-Patent Citations (4)
| Title |
|---|
| 刘锡鲁等: "注射用头孢地嗪钠聚合物测定方法的研究", 《疾病监测与控制杂志》 * |
| 李兰等: "HPLC法测定注射用头孢地嗪钠中MMTA的含量", 《海峡药学》 * |
| 董嘉君等: "凝胶色谱法测定头孢地嗪钠中高分子杂质", 《西北药学杂志》 * |
| 陈晶: "注射用头孢地嗪钠聚合物的检查", 《中国药品标准》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105116076A (en) * | 2015-09-28 | 2015-12-02 | 苏州二叶制药有限公司 | Method for detecting cefodizime sodium related substances |
| CN105116076B (en) * | 2015-09-28 | 2017-06-30 | 苏州二叶制药有限公司 | A kind of detection method of Cefodizime Sodium about material |
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Application publication date: 20141217 |