Method for separating and/or detecting levofloxacin and methylparaben in levofloxacin hydrochloride ophthalmic gel

A technology of levofloxacin hydrochloride and levofloxacin, which is applied in the field of drug analysis, can solve the problems of inability to guarantee the quality attributes of levofloxacin hydrochloride ophthalmic gel, harmful effects on patients, etc., and achieves the quality controllability, easy operation, and short detection time. Effect

Active Publication Date: 2017-05-31
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

However, if the concentration of methyl paraben in the ophthalmic gel is too high, it is easy to have harmful effects on the patient's body, and if the concentration of methyl paraben is too low, it cannot guarantee the efficacy of levofloxacin hydrochloride ophthalmic gel within the validity period. quality attribute

Method used

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  • Method for separating and/or detecting levofloxacin and methylparaben in levofloxacin hydrochloride ophthalmic gel
  • Method for separating and/or detecting levofloxacin and methylparaben in levofloxacin hydrochloride ophthalmic gel
  • Method for separating and/or detecting levofloxacin and methylparaben in levofloxacin hydrochloride ophthalmic gel

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Instrument: Diana U3000 HPLC chromatograph

[0053] Chromatographic column: Dionex Acclaim120 C18 chromatographic column (250mm×4.6mm, 5μm, )

[0054] Mobile phase: mobile phase A: mixed solution of acetonitrile-3.32mg / mL ammonium acetate and 5.26mg / mL sodium perchlorate (adjust pH=2.2 with phosphoric acid)=15:85; mobile phase B: acetonitrile

[0055] The volume content of mobile phase A in the elution time and its corresponding mobile phase is as follows: at 0~18min, the volume content of mobile phase A is 100%; at 18~25min, the volume content of mobile phase A decreases from 100% to 70%; at 25-39min, the volume content of mobile phase A is 70%; at 39-40min, the volume content of mobile phase A increases from 70% to 100%; at 40-50min, the volume content of mobile phase A is 100%.

[0056] Column temperature: 40°C

[0057] Flow rate: 1.0mL / min

[0058] Detection wavelength of levofloxacin and methylparaben: 294nm; 252nm.

[0059] Reference substance solution prep...

Embodiment 2

[0068] Instrument: Agilent 1260 HPLC chromatograph

[0069] Chromatographic column: Agilent ZORBAX Extend-C18 chromatographic column (250mm×4.6mm, 5μm, )

[0070] Mobile phase: acetonitrile-3.00mg / mL ammonium acetate and 5.43mg / mL sodium perchlorate mixed solution (adjust pH to 2.5 with phosphoric acid)=14:86; mobile phase B: acetonitrile

[0071] The volume content of mobile phase A in the elution time and its corresponding mobile phase is as follows: at 0~18min, the volume content of mobile phase A is 100%; at 18~25min, the volume content of mobile phase A decreases from 100% to 70%; at 25-39min, the volume content of mobile phase A is 70%; at 39-40min, the volume content of mobile phase A increases from 70% to 100%; at 40-50min, the volume content of mobile phase A is 100%.

[0072] Column temperature: 38°C

[0073] Flow rate: 1.1mL / min

[0074] The detection wavelengths of levofloxacin and methylparaben are 296nm and 254nm, respectively.

[0075] Relevant solution p...

Embodiment 3

[0081] Instrument: Waters Alliance2695 HPLC chromatograph

[0082] Chromatographic column: Thermo Hypersil-C18 chromatographic column (250mm×4.6mm, 5μm, )

[0083] Mobile phase: acetonitrile-3.85mg / mL ammonium acetate and 6.00mg / mL sodium perchlorate mixed solution (adjust pH=2.4 with phosphoric acid)=11:89; mobile phase B: acetonitrile

[0084] The volume content of mobile phase A in the elution time and its corresponding mobile phase is as follows: at 0~18min, the volume content of mobile phase A is 100%; at 18~25min, the volume content of mobile phase A decreases from 100% to 70%; at 25-39min, the volume content of mobile phase A is 70%; at 39-40min, the volume content of mobile phase A increases from 70% to 100%; at 40-50min, the volume content of mobile phase A is 100%.

[0085] Column temperature: 35°C

[0086] Flow rate: 1.0mL / min

[0087] The detection wavelengths of levofloxacin and methylparaben are 291nm and 247nm respectively

[0088] Relevant solution prepa...

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Abstract

The application discloses a method for separating and/or detecting levofloxacin and methylparaben in levofloxacin hydrochloride ophthalmic gel. The method is a high performance liquid chromatography, and concretely comprises the following steps: preparing a test solution and a reference solution; using octadecyl silane bonded silica gel as a chromatographic column, wherein chromatographic separation test conditions are as follows: the column temperature is 30-40 DEG C, the flow velocity of a mobile phase is 0.9-1.3mL/min, and the ultraviolet detection wavelengths of the levofloxacin and the methylparaben are respectively 240-260nm and 280-300nm; detecting: respectively and precisely absorbing 10mu L of the test solution and 10mu L of the reference solution, injecting into a high performance liquid chromatograph, and reading the chromatographic peak areas of the levofloxacin and the methylparaben in the test solution. The method can accurately and rapidly measure the contents of the levofloxacin and the methylparaben in the levofloxacin hydrochloride ophthalmic gel at the same time, thus providing guarantee for the quality controllability of the levofloxacin hydrochloride ophthalmic gel.

Description

technical field [0001] The application relates to a method for separating levofloxacin and methylparaben in levofloxacin hydrochloride ophthalmic gel and / or detecting the content of levofloxacin and methylparaben in levofloxacin hydrochloride ophthalmic gel, belonging to the technical field of drug analysis. Background technique [0002] Fluoroquinolones represent the left-handed isomer of ofloxacin, which has a broad antibacterial spectrum and has a strong killing effect on aerobic Gram-positive bacteria and negative bacteria. Therefore, domestic and foreign pharmaceutical companies use its good bactericidal effect An ophthalmic gel is prepared. The gel has the characteristics of good water solubility, strong adhesion, high dissolution rate, no greasy feeling, skin and mucous membrane irritation, long-lasting effect, etc., and can be used for the treatment of eye bacterial infection diseases. [0003] Methylparaben is an internationally recognized broad-spectrum high-effic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/33
CPCG01N21/33
Inventor 王超付欢许方云马慧玲刘锐梁琴
Owner 湖北远大天天明制药有限公司
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