CN104165949A - Inspection method for cefodizime sodium polymer for injection - Google Patents
Inspection method for cefodizime sodium polymer for injection Download PDFInfo
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- CN104165949A CN104165949A CN201410434332.0A CN201410434332A CN104165949A CN 104165949 A CN104165949 A CN 104165949A CN 201410434332 A CN201410434332 A CN 201410434332A CN 104165949 A CN104165949 A CN 104165949A
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Abstract
The invention discloses an inspection method for cefodizime sodium polymer for injection. The inspection method disclosed by the invention has the advantages that the amount of related substances of cefodizime sodium for injection is measured by a gradient elution method, more impurities can be detected, and the discovering of the quality problem in a pharmaceutical product is facilitated, so that the improvement of the quality of a product is improved.
Description
Technical field
The present invention relates to pharmacy formulation art, particularly, relate to a kind of inspection method of cefodizime sodium for injection polymkeric 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 this unique substituting group of 2-sulfydryl-4-methyl-5-thiazole acetic acid.Be mainly used in clinically the negative microbial upper lower urinary tract infection of staphylococcus, streptococcus and most of Ge Lan, lower respiratory infection, gonorrhoea etc.
And affect Cefodizime Sodium due to impurity such as Cefodizime Sodium related substance and Cefodizime sodium polymers, be easy to cause that the allergic reaction of medication causes medication to have potential safety hazard, particularly Cefodizime Sodium is in production and storage process, easily produce Cefodizime Sodium related substance and Cefodizime sodium polymer, affect the stability of product.Therefore Cefodizime Sodium is purer, more has security in clinical application.Detecting polymkeric substance in cefodizime sodium for injection plays an important role to safe medication.
Summary of the invention
Technical matters to be solved by this invention is to provide a kind of inspection method of cefodizime sodium for injection polymkeric substance, and the method adopts linear gradient elution method, makes to detect the degree of separation of each composition in sample and the mensuration requirement that Sensitivity all meets related substance limit.
The present invention addresses the above problem adopted technical scheme:
The inspection method of cefodizime sodium for injection polymkeric substance, first set up linear equation, determine sample size scope, by glucose gel chromatographic column, in macromolecule impurity analysis, with ultraviolet 254nm, carry out gradient elution again, wherein, the phosphate buffer of 0.1mol/L of pH7.0 of take is mobile phase A, take deionized water as Mobile phase B, flow velocity is 1.5ml/min, mobile phase A is as the mobile phase of measuring, Mobile phase B is as the mobile phase of setting up linear equation, and with External standard method, measures the content of the polymkeric substance of cefodizime sodium for injection.
Employing glucose gel is filler, and employing internal diameter is 1.3-1.6cm, is highly the filled column of 30-40cm.
Described gradient elution is 0-20min, mobile phase A 95% → 85%; 20-40min, mobile phase A 85% → 80%; 40-45min, mobile phase A 80% → 95%; 45-50min, mobile phase A keeps 95%.
Described phosphate buffer is that potassium dihydrogen phosphate and ADSP are dissolved in water and are diluted to 1000mL.
The method for building up of described linear equation is: precision takes Cefodizime reference substance thin up, take Mobile phase B as mobile phase, and sample introduction 50,100,150,200,250 microlitres, obtain linear equation Y=36839.716X+378258.8 successively, wherein Y is peak area, and X is solution concentration mg/mL.
To sum up, the invention has the beneficial effects as follows:
The present invention measures the amount of the related substance of cefodizime sodium for injection by linear gradient elution method, more impurity can be detected, can contribute to find the quality problems in pharmaceutical products, impels the raising of product quality.
Embodiment
Below in conjunction with embodiment, the present invention is done to detailed description further, but embodiments of the present invention are not limited to this.
Embodiment 1:
The inspection method of cefodizime sodium for injection polymkeric substance, first set up linear equation, determine sample size scope, by glucose gel chromatographic column, in macromolecule impurity analysis, with ultraviolet 254nm, carry out gradient elution again, wherein, the phosphate buffer of 0.1mol/L of pH7.0 of take is mobile phase A, take deionized water as Mobile phase B, flow velocity is 1.5ml/min, mobile phase A is as the mobile phase of measuring, Mobile phase B is as the mobile phase of setting up linear equation, and with External standard method, measures the content of the polymkeric substance of cefodizime sodium for injection.
Employing glucose gel is filler, and employing internal diameter is 1.3-1.6cm, is highly the filled column of 30-40cm.
Described gradient elution is 0-20min, mobile phase A 95% → 85%; 20-40min, mobile phase A 85% → 80%; 40-45min, mobile phase A 80% → 95%; 45-50min, mobile phase A keeps 95%.
Described phosphate buffer is that potassium dihydrogen phosphate and ADSP are dissolved in water and are diluted to 1000mL.
The method for building up of described linear equation is: precision takes Cefodizime reference substance thin up, take Mobile phase B as mobile phase, and sample introduction 50,100,150,200,250 microlitres, obtain linear equation Y=36839.716X+378258.8 successively, wherein Y is peak area, and X is solution concentration mg/mL.
As mentioned above, can realize preferably the present invention.
Claims (5)
1. the inspection method of cefodizime sodium for injection polymkeric substance, it is characterized in that, first set up linear equation, determine sample size scope, by glucose gel chromatographic column, in macromolecule impurity analysis, with ultraviolet 254nm, carry out gradient elution again, wherein, the phosphate buffer of 0.1mol/L of pH7.0 of take is mobile phase A, take deionized water as Mobile phase B, flow velocity is 1.5ml/min, mobile phase A is as the mobile phase of measuring, and Mobile phase B is as the mobile phase of setting up linear equation, and with External standard method, measures the content of the polymkeric substance of cefodizime sodium for injection.
2. the inspection method of cefodizime sodium for injection polymkeric substance according to claim 1, is characterized in that, employing glucose gel is filler, and employing internal diameter is 1.3-1.6cm, is highly the filled column of 30-40cm.
3. the inspection method of cefodizime sodium for injection polymkeric substance according to claim 1, is characterized in that, described gradient elution is 0-20min, mobile phase A 95% → 85%; 20-40min, mobile phase A 85% → 80%; 40-45min, mobile phase A 80% → 95%; 45-50min, mobile phase A keeps 95%.
4. the inspection method of cefodizime sodium for injection polymkeric substance according to claim 1, is characterized in that, described phosphate buffer is that potassium dihydrogen phosphate and ADSP are dissolved in water and are diluted to 1000mL.
5. the inspection method of cefodizime sodium for injection polymkeric substance according to claim 1, it is characterized in that, the method for building up of described linear equation is: precision takes Cefodizime reference substance thin up, take Mobile phase B as mobile phase, sample introduction 50,100,150,200,250 microlitres successively, obtain linear equation Y=36839.716X+378258.8, wherein Y is peak area, and X is solution concentration mg/mL.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201410434332.0A CN104165949A (en) | 2014-08-29 | 2014-08-29 | Inspection method for cefodizime sodium polymer for injection |
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| CN201410434332.0A CN104165949A (en) | 2014-08-29 | 2014-08-29 | Inspection method for cefodizime sodium polymer for injection |
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| CN104165949A true CN104165949A (en) | 2014-11-26 |
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Cited By (3)
| 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 |
| CN110361475A (en) * | 2019-08-05 | 2019-10-22 | 南京明捷生物医药检测有限公司 | The detection method of polymer in a kind of measurement cephalosporin analog antibiotic |
| CN112067709A (en) * | 2020-07-03 | 2020-12-11 | 海口市制药厂有限公司 | Method for determining cefodizime sodium related substance for injection and application |
-
2014
- 2014-08-29 CN CN201410434332.0A patent/CN104165949A/en active Pending
Non-Patent Citations (5)
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| 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》 * |
| 陈晶: "注射用头孢地嗪钠聚合物的检查", 《中国药品标准》 * |
| 陈晶: "注射用头孢地嗪钠聚合物的检查", 《中国药品标准》, vol. 7, no. 6, 31 December 2006 (2006-12-31), pages 1 - 5 * |
| 陶君等: "头孢地嗪钠原料药中聚合物的测定", 《天津中医药》 * |
Cited By (4)
| 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 |
| CN110361475A (en) * | 2019-08-05 | 2019-10-22 | 南京明捷生物医药检测有限公司 | The detection method of polymer in a kind of measurement cephalosporin analog antibiotic |
| CN112067709A (en) * | 2020-07-03 | 2020-12-11 | 海口市制药厂有限公司 | Method for determining cefodizime sodium related substance for injection and application |
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Application publication date: 20141126 |