A kind of detection method of cefuroxime sodium polymer impurities
A cefuroxime sodium and polymer technology, applied in the field of high-performance liquid chromatography detection, can solve the problems of long analysis period, poor mechanical strength, weak compression resistance, etc., and achieve the effect of good method popularization and shortened detection time
Active Publication Date: 2011-11-30
GUANGZHOU LIXIN PHARM CO LTD
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Problems solved by technology
The 2000 and 2005 editions of the Chinese Pharmacopoeia have also increased the inspection items for condensates by this method [National Pharmacopoeia Committee, Pharmacopoeia of the People's Republic of China, 2005 edition, Beijing: Chemical Industry Press, 2005, 141], but the gel chromatography used Sephadex G-10 filler is a kind of hydrophilic gel, which has poor mechanical strength and weak compression resistance. It needs to use a low-pressure type (preparative) chromatograph for detection, and the gel particle size is 40-120 μm, which leads to the existence of this method. Disadvantages such as low column efficiency and long analysis cycle
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Embodiment 1
[0049] Chromatographic conditions: detection machine: Diane Summit high performance liquid chromatography system; chromatographic column: MKF-GPC-10 (100mm×7.8mm, 5μm); mobile phase: 0.01mol / L phosphate buffer (pH7.0) -Acetonitrile (70:30); Flow rate: 1mL / min; Detection wavelength: 254nm; Injection volume: 20 μ L; image 3 .
Embodiment 2
[0051] Chromatographic conditions: detection instrument, chromatographic column, detection wavelength, sample volume, sample material are the same as in Example 1, mobile phase: phosphate buffer (pH7.5)-acetonitrile (75:25) of 0.02mol / L; flow velocity : 0.8mL / min, the result is as follows Figure 4 .
Embodiment 3
[0053] Chromatographic conditions: detection instrument, chromatographic column, detection wavelength, sample volume, sample material are the same as in Example 1, mobile phase: phosphate buffer (pH7.0)-acetonitrile (60:40) of 0.02mol / L; flow velocity : 0.8mL / min, the result is as follows Figure 5 .
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Abstract
The invention relates to a method for detecting polymer impurities or condensate impurities in cefuroxime sodium. The present invention adopts high-performance liquid chromatography, chromatographic conditions: polystyrene-divinylbenzene high polymer chromatographic column: MKF-GPC-10, 4~10 μ m, (100~300)×(8.0~4.6) mm (I.D. ), the mobile phase composition volume ratio is 0.005~0.1mol / L phosphate buffer (pH=6~8) and the volume ratio of acetonitrile is 60~80:40~20, flow rate: 0.8~1.2mL / min, detection Wavelength: 254±10nm, sample injection volume: 10-20 μL; the present invention overcomes the disadvantages of proto-sephadex analysis, such as long analysis time and high requirements for instruments.
Description
(1) Technical field [0001] The invention relates to a high-performance liquid chromatography (HPLC) detection method, in particular to an analysis method for detecting polymer or condensate impurities in cefuroxime sodium using a polystyrene gel chromatography medium as a separation carrier. (2) Background technology [0002] β-lactam antibiotics are widely used clinically, and a large number of experiments and clinical experiments have proved that various polymer impurities (usually referred to as "polymers" in this field, but from the perspective of mechanism and structural molecular weight) It should be a dimeric condensate, or a trimeric condensate, or a polycondensate, or a mixture of different condensates, therefore, "condensate" is also used below) is the real allergen that causes the immediate allergic reaction, so the detection And controlling the content of condensate impurities in the product is the fundamental way to reduce the allergic reaction of β-lactam antib...
Claims
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IPC IPC(8): G01N30/02G01N30/36G01N30/74
Inventor 刘晓宁魏荣卿方硕
Owner GUANGZHOU LIXIN PHARM CO LTD