Method for determining content of azithromycin in azithromycin sustained-release eye drops

A technology for slow-release eye drops and azithromycin, which is applied in the field of content determination of azithromycin in Chinese medicine, can solve the problems of low recovery rate, determination of drug content, leakage of the main drug, etc., and achieve time and cost reduction, accurate detection data, and specificity strong effect

Active Publication Date: 2013-10-30
QILU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Since the azithromycin sustained-release eye drops contain the above-mentioned polymer excipients and cannot be directly filtered out, it cannot directly enter the chromatographic column for high-performance liquid chromatography to determine the drug content.
Prior art personnel have carried out many researches to sample processing method, and processing method comprises: (1) enhanced ionic strength method: according to the structural characteristic of polycarbophil, try to make polycarbophil denaturation by changing ionic strength so as to reach removal However, while removing polycarbophil, the main drug is also precipitated in large quantities, and the recovery rate is extremely low, which cannot meet the determination requirements; (2) dialysis method: put azithromycin sustained-release eye drops into a dialysis bag, put an appropriate amount of Dialysis in the solute can not fully reveal the main drug, the recovery rate is low, and cannot meet the determination requirements; (3) extraction method: use organic solvents such as chloroform, ethyl acetate, ether to extract the main drug, and the result is that the main drug is degraded , cannot be used; (4) ultrafiltration method: properly dilute azithromycin sustained-release eye drops, pass through the ultrafiltration membrane, the recovery rate is also low, and cannot meet the determination requirements
Therefore, none of the existing sample processing methods can accurately detect the content of azithromycin in azithromycin sustained-release eye drops

Method used

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  • Method for determining content of azithromycin in azithromycin sustained-release eye drops
  • Method for determining content of azithromycin in azithromycin sustained-release eye drops
  • Method for determining content of azithromycin in azithromycin sustained-release eye drops

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Mobile phase: methanol-acetonitrile-0.02mol dipotassium hydrogen phosphate buffer (adjust pH=7.2 with phosphoric acid)=50:10:40;

[0045] Determination steps:

[0046]Weigh 5g of azithromycin sustained-release eye drops sample, place it in a 25ml volumetric flask, add mobile phase to half of the volumetric flask, shake gently, and set the volume to the mark. Weigh 50 mg of azithromycin reference substance, place it in a 25ml volumetric flask, add mobile phase to dissolve the reference substance and dilute to the mark with mobile phase. Take the reference substance solution and the sample solution respectively and pass through a 0.22 μm filter membrane, carry out high-performance liquid chromatography analysis according to the above conditions, and record the chromatogram. The obtained chromatogram shows that under this condition, the main peak of azithromycin can be completely separated from the auxiliary material peak. According to reference substance concentration / s...

Embodiment 2

[0048] Mobile phase: methanol-acetonitrile-0.02mol disodium hydrogen phosphate buffer volume ratio (adjust pH=7.2 with phosphoric acid)=20:50:30;

[0049] Determination steps:

[0050] Quantitatively weigh 5g of azithromycin sustained-release eye drops sample, place it in a 25ml volumetric flask, add mobile phase to half of the volumetric flask, shake gently, and set the volume to the mark. Weigh 50mg of azithromycin reference substance, place it in a 25ml volumetric flask, add mobile phase to dissolve and dilute to the mark. Take the reference substance solution and the sample solution respectively and pass through a 0.22 μm filter membrane to carry out high-performance liquid chromatography analysis according to the above conditions, and record the chromatograms. The obtained chromatograms are shown in the attached figure 1 As shown, it can be seen that the azithromycin main peak 1 can be completely separated from the auxiliary material peak under this condition, and the az...

Embodiment 3

[0053] Mobile phase: methanol-acetonitrile-0.02mol dipotassium hydrogen phosphate buffer volume ratio (adjust pH=6.8 with phosphoric acid)=60:20:20;

[0054] Determination steps:

[0055] Quantitatively weigh 5g of azithromycin sustained-release eye drops sample, place it in a 25ml volumetric flask, add mobile phase to half of the volumetric flask, shake gently, and set the volume to the mark. Weigh 50mg of azithromycin reference substance, place it in a 25ml volumetric flask, add mobile phase to dissolve and dilute to the mark. The reference substance solution and the sample solution were respectively passed through a 0.22 μm filter membrane and analyzed by high performance liquid chromatography according to the above conditions, and the obtained spectrum showed that the main peak of azithromycin could be completely separated from the peak of the auxiliary material under this condition. According to reference substance concentration / sample concentration=contrast peak area / sa...

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Abstract

The invention relates to a method for determining content of azithromycin in azithromycin sustained-release eye drops. The method comprises the following steps of: preparing a mobile phase by using an organic solvent and a buffer solution in a volume ratio of (40-90):(60-20), wherein the pH value of the mobile phase is 5 to 10; and solving an azithromycin eye drop sample and a reference substance by using the mobile phase respectively, determining the content of azithromycin by high performance liquid chromatography, performing sample introduction on the prepared sample solution and the reference substance solution respectively and recording a chromatogram. The samples are solved by using the mobile phase in a specific ratio, so that the high polymer polycarbophil contained in azithromycin sustained-release eye drops can be completely precipitated, the content determination of a medicine is not influenced, the chromatographic peak of a main medicine azithromycin can be completely separated from the chromatographic peaks of auxiliary materials, and detection accuracy can be improved.

Description

technical field [0001] The invention relates to a method for determining the content of azithromycin in the azithromycin sustained-release eye drops, in particular to a method for determining the content of azithromycin in the azithromycin sustained-release eye drops with the pharmaceutical auxiliary material Polycarbofil (PolycarbopHil) as the sustained-release matrix. Background technique [0002] Azithromycin is a 15-membered ring macrolide antibiotic with a broad antibacterial spectrum. In addition to having antibacterial effects against most bacteria, it also has good activity against chlamydia and mycoplasma. The mechanism of action is the same as that of erythromycin. It mainly binds to the 50S subunit of bacterial ribosomes and inhibits RNA-dependent protein synthesis. It is widely used clinically for acute pharyngitis and acute tonsillitis caused by Streptococcus pyogenes; sinusitis, otitis media, acute bronchitis and acute exacerbation of chronic bronchitis caused ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/36
Inventor 王晶翼李红英邱丽明李磊张明会
Owner QILU PHARMA CO LTD
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