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Tobramycin raw material and related preparation impurity spectrum analysis method

A technology of tobramycin and analytical methods, applied in the direction of material separation, analytical materials, instruments, etc., can solve problems such as inappropriateness, high proficiency requirements, and deviations, and achieve good specificity, strong scalability, and responsiveness fast effect

Active Publication Date: 2020-09-22
SHANGHAI INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 1) The HPLC-PAD method requires high reagent purity and operator proficiency, and the cost of electrochemical detectors is several times that of other detectors. The stability and universality of the method need to be continuously verified;
[0006] 2) The pre-column derivatization method has problems such as many derivatization by-products and the detection of impurities such as derivatization reagents, etc., which are not suitable for the analysis of tobramycin impurity profile;
[0007] 3) The repeatability and reproducibility of the HPLC-ELSD method are poor. This problem has the reasons of the ELSD instrument itself, and also has the deviation of the instrument operator's understanding of the standard, such as the parameters of the low-temperature ELSD instrument and the parameters of the high-temperature ELSD instrument. conversion problem

Method used

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  • Tobramycin raw material and related preparation impurity spectrum analysis method
  • Tobramycin raw material and related preparation impurity spectrum analysis method
  • Tobramycin raw material and related preparation impurity spectrum analysis method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Solution preparation:

[0057] 1. Buffered saline solution containing ion pair reagent

[0058] Take 16 g of anhydrous sodium sulfate and 4.4 g of sodium heptane sulfonate, add 1000 ml of water to dissolve, and adjust the pH to 3.4 with glacial acetic acid.

[0059] 2. Mobile phase A

[0060] Methanol and the above-mentioned buffered saline solution containing ion pair reagent are mixed in a volume ratio of 5:95.

[0061] 3. Mobile Phase B

[0062] Methanol and the above-mentioned buffered saline solution containing ion pair reagent are mixed in a volume ratio of 40:60.

[0063] 4. Mix the reference solution

[0064] Accurately weigh tobramycin A, neomycamine, darkmycamine, kanamycin B and tobramycin reference substances, dissolve in water and dilute to a concentration of 0.1 mg / ml for each reference substance mentioned above.

[0065] 5. Alkali degradation solution

[0066] Accurately weigh the tobramycin reference substance, add water to dissolve and dilute to a concentration of 0.5...

Embodiment 2

[0072] Weigh accurately tobramycin sulfate injection (source B, specification 40mg / ml), add water to dissolve and dilute to a concentration of 0.24mg / ml.

[0073] Weigh accurately tobramycin sulfate injection (source C, specification 40mg / ml), add water to dissolve and dilute to a concentration of 0.24mg / ml.

[0074] Using the same instrument and detection conditions as in implementation 1, sample injection analysis, the results are as follows Figure 4-5 Shown.

Embodiment 3

[0076] Accurately weigh tobramycin dexamethasone eye drops (source D, containing tobramycin 3mg / ml), dissolve in water and dilute to a concentration of 0.24mg / ml.

[0077] Accurately weigh loteprednol tobramycin eye drops (source E, containing tobramycin 3mg / ml), dissolve in water and dilute to a concentration of 0.24mg / ml.

[0078] Using the same instrument and detection conditions as in implementation 1, sample injection analysis, the results are as follows Figure 6-7 Shown.

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Abstract

The invention discloses a tobramycin raw material and related preparation impurity spectrum analysis method. A post-column derivatization-high performance liquid chromatography fluorescence detectionmethod is adopted. The analysis method disclosed by the invention adopts a post-column derivatization-high performance liquid chromatography fluorescence detection (HPLC-FLD) method, has the advantages of high reaction speed, no interference of a derivatization reagent on measurement and the like, can effectively separate process impurities and degraded impurities through screening and optimization of chromatographic conditions, and is relatively high in sensitivity at the same time, analyzes on samples with complex matrixes, such as suspension type eye drops and eye cream, proves that the method is good in specificity and high in generalizability.

Description

Technical field [0001] The invention relates to the field of drug analysis, in particular to a method for analyzing the impurity spectrum of tobramycin raw materials and related preparations. Background technique [0002] Tobramycin is an aminoglycoside antibiotic with broad-spectrum antibacterial activity obtained by the fermentation of Streptomyces tenebrarius ATCC 17920. It is mainly used clinically for serious infections caused by sensitive bacteria, such as burn infections, sepsis, respiratory system infections, urinary system infections, gallbladder and biliary tract infections and severe soft tissue infections caused by Gram-positive bacteria, especially Pseudomonas aeruginosa, Escherichia coli and Pneumoniae. Wait. After intramuscular injection, the absorption is rapid and complete, and it is not metabolized in the body, but is excreted through glomerular filtration. 85% to 93% of the dose is discharged within 24h. The main adverse reactions are ototoxicity and nephrot...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/067G01N2030/047
Inventor 赵敬丹刘雅茜吕丹丹刘浩张含智秦峰范迪
Owner SHANGHAI INST FOR FOOD & DRUG CONTROL
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