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Separation and detection method of related substances in ophthalmic gel

A technology for related substances and ophthalmic gels, which is applied in the field of separation and detection of related substances in ophthalmic gels, can solve problems such as adverse effects on safety and effectiveness, complex components, etc., to ensure safety and quality. Properties, short detection time, good column efficiency

Active Publication Date: 2020-04-10
湖北远大天天明制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Due to the complex composition of levofloxacin hydrochloride ophthalmic gel, impurities in raw materials and impurities produced in production and storage will have adverse effects on the safety and effectiveness of the drug. In order to ensure the safety of levofloxacin hydrochloride ophthalmic gel properties and quality attributes, it is necessary to provide an assay method capable of detecting its related impurity components

Method used

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  • Separation and detection method of related substances in ophthalmic gel
  • Separation and detection method of related substances in ophthalmic gel
  • Separation and detection method of related substances in ophthalmic gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Dilute the levofloxacin hydrochloride ophthalmic gel with 0.1 mol / L hydrochloric acid to a concentration of 1 mg / mL, centrifuge at 3000 r / min for 15 min, and take the supernatant as the analyte solution.

[0074] The hydroxybenzoic acid reference substance and the ciprofloxacin reference substance are respectively diluted with water to obtain the hydroxybenzoic acid reference solution and the ciprofloxacin reference solution. Dilute the impurity E reference substance with 0.1 mol / L hydrochloric acid to a concentration of 5 μg / mL to obtain the impurity E reference solution. Dilute the impurity A reference substance with 6 mol / L ammonia water and water to a concentration of 0.15 mg / mL to obtain the impurity A reference solution.

[0075] Take 10 μL of the analyte solution, the hydroxybenzoic acid reference solution, the impurity E reference solution, the ciprofloxacin reference solution and the impurity A reference solution, respectively, inject 10 μL into the Dionex U300...

Embodiment 2

[0086] Dilute the levofloxacin hydrochloride ophthalmic gel with 0.05 mol / L hydrochloric acid to a concentration of 0.5 mg / mL, centrifuge at 2500 r / min for 20 min, and take the supernatant as the solution to be tested.

[0087] The hydroxybenzoic acid reference substance and the ciprofloxacin reference substance are respectively diluted with water to obtain the hydroxybenzoic acid reference solution and the ciprofloxacin reference solution. Dilute the impurity E reference substance with 0.08mol / L hydrochloric acid to a concentration of 4.5 μg / mL to obtain the impurity E reference solution. Dilute the impurity A reference substance with 5 mol / L ammonia water and water to a concentration of 0.1 mg / mL to obtain the impurity A reference solution.

[0088] Take 15 μL of the test substance solution, the hydroxybenzoic acid reference solution, the impurity E reference solution, the ciprofloxacin reference solution and the impurity A reference solution, respectively, inject 15 μL into...

Embodiment 3

[0099] Dilute the levofloxacin hydrochloride ophthalmic gel with 0.5mol / L hydrochloric acid to a concentration of 1.5mg / mL, centrifuge at 3500r / min for 10min, and take the supernatant as the analyte solution.

[0100] The hydroxybenzoic acid reference substance and the ciprofloxacin reference substance are respectively diluted with water to obtain the hydroxybenzoic acid reference solution and the ciprofloxacin reference solution. Dilute the impurity E reference substance with 0.12mol / L hydrochloric acid to a concentration of 5.5 μg / mL to obtain the impurity E reference solution. Dilute the impurity A reference substance with 7 mol / L ammonia water and water to a concentration of 0.2 mg / mL to obtain the impurity A reference solution.

[0101] Take respectively 20 μL of test substance solution, hydroxybenzoic acid reference solution, impurity E reference solution, ciprofloxacin reference solution and impurity A reference solution, inject into Waters Alliance2695 high performance...

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Abstract

Belonging to the field of pharmaceutical analysis, the invention relates to a separation and detection method for related substances in an ophthalmic gel. The method includes: preparing a to-be-detected solution, performing sample introduction, and conducting separation under the following conditions that: the chromatographic column is octadecyl silane bonded silica gel, the mobile phase is an acetonitrile-buffer solution and acetonitrile, the volume content of the mobile phase B is: 0% at 0-18min; 0-30% at 18-25min; 30% at 25-39min; 30-0% at 39-40min; and 0% at 40-50min; and conducting detection. The method can effectively separate related substances in the to-be-detected material. The control solutions of the related substances are prepared, the same method is adopted for high performance liquid chromatographic analysis, the peak area is read, and the content of each substance in the to-be-detected material is calculated. The method can rapidly and accurately determine the content of related substances in the to-be-detected material simultaneously, and is convenient for control of the product quality.

Description

technical field [0001] The invention relates to the field of drug analysis, and in particular to a method for separating and detecting related substances in an ophthalmic gel. Background technique [0002] Fluoroquinolones represent the levorotatory isomer of ofloxacin, which has a broad antibacterial spectrum and has a strong killing effect on aerobic Gram-positive and negative bacteria. Therefore, domestic and foreign pharmaceutical companies use its good bactericidal effect. An ophthalmic gel was prepared. The gel has the characteristics of good water solubility, strong adhesion, high dissolution, no greasy feeling, irritation to skin and mucous membranes, and long-lasting effect, and can be used for the treatment of bacterial infections in the eyes. [0003] Due to the complex composition of levofloxacin hydrochloride ophthalmic gel, impurities in raw and auxiliary materials and impurities generated from production and storage will adversely affect the safety and effect...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 王超付欢延静许方云马慧玲
Owner 湖北远大天天明制药有限公司
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