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High performance liquid chromatograph method used for measuring content of netilmicin sulfate

A technology of netilmicin sulfate and high performance liquid chromatography, which is applied in the direction of measuring devices, analysis materials, material separation, etc., can solve the problems of damage to instruments and chromatographic columns, large consumption, and impact on service life, and achieve a wide linear range , high recovery and high sensitivity

Inactive Publication Date: 2018-10-09
江苏省食品药品监督检验研究院 +2
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  • Application Information

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Problems solved by technology

However, the ion-pair reagents used are expensive and consume a large amount, resulting in high analysis costs. The high concentration of salt in the mobile phase and solvent seriously damages the instrument and chromatographic column, affecting its service life.

Method used

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  • High performance liquid chromatograph method used for measuring content of netilmicin sulfate
  • High performance liquid chromatograph method used for measuring content of netilmicin sulfate
  • High performance liquid chromatograph method used for measuring content of netilmicin sulfate

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Experimental program
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Effect test

Embodiment 1

[0044] Embodiment 1 mobile phase and solvent investigation

[0045] System suitability solution: get two parts of netilmicin standard substance and sisomicin standard substance each about 17mg, put in 10ml volumetric flask, USP40 method adopts mobile phase to dissolve and dilute to scale, the method of the present invention adopts water to dissolve and Dilute to the mark.

[0046] The mobile phase composition under the USP40 content item is sodium heptanesulfonate dilute phosphoric acid solution (20.22g / L sodium heptanesulfonate is dissolved in 0.5% dilute phosphoric acid solution): acetonitrile=62:38.

[0047] The mobile phase of the method of the present invention consists of sodium heptanesulfonate buffer (6g / L sodium heptanesulfonate+13.6g / L potassium dihydrogen phosphate, phosphoric acid to adjust the pH to 2.5): acetonitrile=77:23.

[0048] USP method and the system suitability solution typical chromatogram of the gained method of the present invention are as figure 1 ...

Embodiment 2

[0052] Embodiment 2 system suitability solution concentration investigation ( image 3 with 4 )

[0053] Prepare system suitability solutions with concentrations of 0.5mg / ml and 0.25mg / ml, inject samples and record chromatograms respectively, and the chromatographic parameters of system suitability solutions with different concentrations are shown in Table 2:

[0054] Table 2 Chromatographic parameters of system suitability solutions at different concentrations

[0055]

[0056] According to the three parameters of resolution, number of theoretical plates and tailing factor in Table 2, the system suitability concentration was determined to be 0.25 mg / ml.

Embodiment 3

[0057] Embodiment 3 specificity investigation ( Figure 5 with Image 6 )

[0058] A reference substance solution with a concentration of 0.25 mg / ml was prepared, and the reference substance solution and water were injected into samples respectively and the chromatograms were recorded. The results showed that the method of the present invention had strong specificity.

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Abstract

The invention discloses a high performance liquid chromatograph method used for measuring the content of netilmicin sulfate. The method comprises the following steps of taking octadecyl silane as a filler and adding a monopotassium phosphate buffer solution (pH2.5)-acetonitrile added with sodium heptanesulfonate as a flowing phase (77:23), wherein the solvent is water, the detection wavelength is205 nm, the velocity is 1 ml / min, and the injection volume is 20 [mu]l. The result of the method has no remarkable difference from the result of the antibiotic microbial assay, a liquid chromatogram system is convenient to operate, the cost for analysis and detection is low, the ideal separation effect is achieved, and the method is strong in specificity, good in degree of precision and high repeatability and accuracy, and provides a reliable technical means for rapidly accurately measuring the content of the netilmicin sulfate.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a high-performance liquid chromatography analysis method for determining the content of netilmicin sulfate. Background technique [0002] Netilmicin sulfate is a semi-synthetic aminoglycoside antibiotic prepared by reacting sisomicin with acetaldehyde and sodium cyanoborohydride. The antibiotic is stable against aminoglycoside acetyltransferases and is particularly sensitive to strains that produce aminoglycoside acetyltransferases and are resistant to other aminoglycoside antibiotics. Netilmicin sulfate is a mild and rare aminoglycoside drug with mild nephrotoxicity. Its ototoxicity is lower than that of gentamicin, tobramycin and amikacin, and its clinical efficacy is better than that of gentamicin. Because of its safety and effectiveness, it has become the drug of choice for the clinical treatment of severe infections caused by sensitive Gram-negative bacilli, including...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74G01N30/86
CPCG01N30/06G01N30/74G01N30/8634
Inventor 袁耀佐赵述强赵卫居斌李健峰史孙亮张玫史清水樊夏雷
Owner 江苏省食品药品监督检验研究院
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