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Determination method for related substances of Bromfenac sodium eye drops

A method of determination, the technology of bromfenac sodium, is applied in the direction of measuring devices, instruments, scientific instruments, etc. It can solve the problems of degraded impurities, affecting product quality, etc., and achieve the effects of good separation, high sensitivity, and strong specificity

Active Publication Date: 2017-02-15
山东辰欣佛都药业股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] During the placement of bromfenac sodium eye drops, degradation impurities will be produced, which will affect the quality of the product

Method used

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  • Determination method for related substances of Bromfenac sodium eye drops
  • Determination method for related substances of Bromfenac sodium eye drops
  • Determination method for related substances of Bromfenac sodium eye drops

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Embodiment 1

[0031] Use liquid chromatography to analyze the related substances of bromfenac sodium eye drops, adopt N-lycoperpine oxide M bonded silica gel column, use phosphate buffer saline-acetonitrile as mobile phase, carry out gradient elution, detection wavelength is 266nm, The flow rate is to adjust the peak eluting time of bromfenac sodium to about 18 minutes, the column temperature is room temperature, and the injection volume is 60uL; the elution gradient program is as follows:

[0032] time (minutes) Mobile phase A(%) mobile phase B 0 100 0 20.1 100 0 60.1 10 90 60.2 100 0 80 100 0

[0033] Mobile phase A described therein: phosphate buffer (take 2.64g of diammonium hydrogen phosphate, add water to dissolve and dilute to 1000ml, adjust the pH value to 7.3 with phosphoric acid)-acetonitrile (75:25); mobile phase B: phosphate Buffer solution (take 2.64g of diammonium hydrogen phosphate, add water to dissolve and dilute to 1000ml, adj...

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Abstract

Belonging to the technical field of drug detection, the invention in particular relates to a determination method for related substances of Bromfenac sodium eye drops. The determination method includes the specific steps of: adopting an octadecyl silane bonded silica gel column or Lycopodine N-oxide M bonded silica gel column, and taking a phosphate buffer solution-acetonitrile as the mobile phase to conduct gradient elution, and setting the detection wavelength at 250-280nm, the column temperature at 10-30DEG C, the flow rate at 0.8-3ml / min, and a sample size of 20-70 microliter. Compared with the prior art, the determination method for related substances of Bromfenac sodium eye drops provided by the invention realizes separation and analysis of Bromfenac sodium and its related substances, and has the characteristics of good separation degree, strong specificity and high sensitivity, and can quantitate the three known impurities by self-control method without correction factor. The determination method has important practical significance for the quality control of Bromfenac sodium eye drops.

Description

technical field [0001] The invention belongs to the technical field of drug detection, and in particular relates to a method for determining related substances of bromfenac sodium eye drops. Background technique [0002] Bromfenac sodium is a derivative of 2-amino-3-benzoylphenylacetic acid, its structure is similar to ketoprofen and diclofenac, it can inhibit the synthesis of prostaglandin inflammatory mediators mediated by cyclooxygenase, and is the most effective One of the most popular cyclooxygenase inhibitors, it has strong anti-inflammatory and analgesic effects, and the strength of the effect is 10 times that of other non-steroidal anti-inflammatory drugs (NSAIDs). Pharmacological experiments showed that bromfenac sodium had anti-inflammatory effects on rat experimental acute conjunctival edema induced by arachidonic acid and carrageenan; Concentration increases. In 2000, Japan approved the listing of bromfenac sodium eye drops of Senju Company, the product name is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 张园园孙文敬李贤张辰辰范锋
Owner 山东辰欣佛都药业股份有限公司
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