Method for detecting 2-mercaptobenzothiazole in ceftriaxone sodium

A technology of mercaptobenzothiazole and ceftriaxone sodium, which is applied in the field of detection of 2-mercaptobenzothiazole in ceftriaxone sodium, can solve problems such as uncontrollable safety of ceftriaxone sodium, and improve drug safety and sensitivity High and control the effect of product quality

Active Publication Date: 2019-12-20
SHANDONG LUKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, there is no relevant report on the detection method of 2-mercaptobenzothiazole in ceftriaxone sodium, and the safety of ceftriaxone sodium cannot be controlled.

Method used

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  • Method for detecting 2-mercaptobenzothiazole in ceftriaxone sodium
  • Method for detecting 2-mercaptobenzothiazole in ceftriaxone sodium
  • Method for detecting 2-mercaptobenzothiazole in ceftriaxone sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Prepare the reference substance solution: accurately weigh the 2-mercaptobenzothiazole reference substance, dissolve it in a solvent, and quantitatively dilute it into a 2-mercaptobenzothiazole solution with a concentration of 0.1 μg / mL as the reference substance solution. The solvent is water and Acetonitrile is the mixed solution obtained by mixing the ratio of 60:40 by volume;

[0068] Prepare the test solution: dissolve ceftriaxone sodium in the solvent, and quantitatively dilute it into a solution with a concentration of 10 mg / mL, as the test solution; the solvent is water and acetonitrile mixed in a ratio of 60:40 by volume to obtain the mixture;

[0069] Reference substance solution and need testing solution are carried out HPLC analysis, obtain the spectrogram of reference substance solution and need testing solution, the condition of HPLC analysis is:

[0070] Chromatographic column: Agilent ZORBAX SB-Aq C18, 4.6mm×250mm, 5μm;

[0071] Mobile phase: 1% formic...

Embodiment 2

[0078] Exclusive experiment:

[0079] Prepare a blank solvent: water and acetonitrile are mixed in a volume ratio of 60:40 to obtain a blank solvent;

[0080] Prepare test solution and reference substance solution according to the method of embodiment 1;

[0081] Blank solvent, reference substance solution, need testing solution are carried out high performance liquid chromatography analysis according to the condition in embodiment 1 successively, the result is as follows Figure 1~4 and shown in Table 1.

[0082] Depend on Figure 1~4 As can be seen from Table 1, the blank solvent does not interfere with the determination of the sample, and in the test solution, the degree of separation between 2-mercaptobenzothiazole and adjacent peaks is greater than 1.5, indicating that the specificity of the detection method provided by the present invention is good.

[0083] The spectrogram information of table 1 blank solvent, reference substance solution and need testing solution

...

Embodiment 3

[0087] Determination of quantitation limit and detection limit:

[0088] The reference substance solution was diluted step by step, and carried out high performance liquid chromatography analysis according to the aforementioned test method, the concentration at which the signal-to-noise ratio (S / N) was about 10 was used as the limit of quantitation concentration, and the concentration when the S / N was about 3 was used as Detection limit concentration, the results are shown in Table 3, as Figure 5 and Figure 6 Shown are the HPLC chromatograms of the solutions with the quantification limit concentration and detection limit concentration respectively. As can be seen from Table 3, the quantification limit concentration is equivalent to the percentage (%) of sample concentration (10mg / mL) and is 0.00005% (i.e. 0.5ppm), and the detection limit concentration is equivalent to the percentage (%) of sample concentration of 0.000015% (i.e. 0.15ppm ), indicating that the detection met...

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Abstract

The present invention provides a method for detecting 2-mercaptobenzothiazole in ceftriaxone sodium, and belongs to the technical field of drug quality detection. According to the method, to-be-detected ceftriaxone sodium is dissolved in a solvent, to obtain a test solution; high-performance liquid chromatography is performed on the test solution, to obtain a spectrogram, wherein conditions of thehigh-performance liquid chromatography are: for a chromatographic column: a filler is octadecylsilane chemically bonded silica; a moving phase is 1% formic acid aqueous solution-acetonitrile, and isocratic elution is performed; a detector is an ultraviolet detector; and then a content of the 2-mercaptobenzothiazole according to the spectrogram. According to the method, the content of the 2-mercaptobenzothiazole in the ceftriaxone sodium can be effectively detected, so that product quality is effectively controlled, and drug medication safety is improved. In addition, sensitivity of the detection method provided in the present invention is relatively high, a quantification limiting concentration is 0.000005 mg / mL, and a detection limiting concentration is 0.0000015 mg / mL.

Description

technical field [0001] The invention relates to the technical field of drug quality detection, in particular to a method for detecting 2-mercaptobenzothiazole in ceftriaxone sodium. Background technique [0002] Ceftriaxone sodium (ceftriaxone sodium), a semi-synthetic third-generation cephalosporin, has strong antibacterial activity, strong penetrating power to the outer membrane and tissue, long-lasting effective blood concentration, stable metabolism in the body, and It has the characteristics of low protein binding rate and can be used for patients with liver or renal insufficiency. Therefore, it is still used in many clinical specialties under the circumstances of the obvious increase in bacterial drug resistance, especially in the antibacterial treatment of outpatient and emergency injections. one of the drugs. In addition, ceftriaxone sodium is listed on the WHO Model List of Essential Medicines and the "National List of Essential Medicines (2018 Edition)", and is th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N2030/027
Inventor 王喃喃刘姣邓丹丹周东东
Owner SHANDONG LUKANG PHARMA
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