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Detection method of pranoprofen eye drop related substances

A detection method and related substance technology, applied in the field of chemical analysis, can solve the problems of small amount of impurities, instability of pranoprofen to light, poor specificity, etc., and achieve good product quality, good durability, and good specificity Effect

Pending Publication Date: 2022-05-27
HANGZHOU XINBOSI BIOMEDICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] There are few reports in the literature on the analysis methods of related substances in pranoprofen eye drops. The Japanese Pharmacopoeia and the Korean Pharmacopoeia have recorded the quality standards for pranoprofen raw materials, but the related substances and methods cannot be applied to pranoprofen eye drops. Detection of related substances
The existing HPLC method for the determination of related substances in pranoprofen eye drops (refer to non-patent literature 1) has poor specificity, and the number of impurities that can be detected is small, and some impurities, including degraded impurities, have not been eluted and cannot Fully reflect product quality and bring potential safety risks to clinical medication
In addition, pranoprofen is unstable to light and is prone to photodegradation to produce degraded impurities. During the placement process, oxidative degradation impurities will gradually be produced. In order to further ensure the product quality of pranoprofen eye drops and the drug safety of patients, there are It is necessary to develop a new detection method, which can better detect the related substances and degradation impurities of pranoprofen eye drops, and ensure the product quality

Method used

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  • Detection method of pranoprofen eye drop related substances
  • Detection method of pranoprofen eye drop related substances
  • Detection method of pranoprofen eye drop related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Embodiment 1: detection of related substances of pranoprofen eye drops

[0046] (1) High performance liquid chromatography conditions:

[0047] Chromatographic column: Agilent infinitylab proshell 120 EC-C18, (3.0×100mm, 2.7µm)

[0048] Detection wavelength: 254nm&274nm

[0049] Injection volume: 20µL

[0050] Column temperature: 25°C

[0051] Sample concentration: 0.2mg / mL

[0052] Flow rate: 0.5mL / min

[0053] Mobile phase: mobile phase A: 0.10mol / L ammonium acetate buffer (adjust the pH to 4.50±0.02 with glacial acetic acid); mobile phase B: acetonitrile.

[0054] Gradient elution time and flow ratios are as follows:

[0055]

[0056] (2) Sample and solution preparation:

[0057] Blank excipient mixture: weigh 1.6g of boric acid, 0.8g of borax, 10mg of edetate disodium hydrate, 7mg of benzalkonium chloride, 0.15g of polysorbate 80, add 80mL of water for injection and stir until dissolved, then add water for injection to volume To 100mL, shake well, that is...

Embodiment 2

[0070] Example 2: Methodological Validation

[0071] 1. Precision test

[0072] Instrument and chromatographic conditions are all with embodiment 1.

[0073] repeatability

[0074] Precisely measure 1 mL of pranoprofen eye drops, put it in a 5 mL measuring bottle, dilute to the mark with diluent, and shake well. Configure 6 copies in parallel. Take 6 parts of blank solution, blank auxiliary material solution, and repeatability test solution respectively, inject samples using the chromatographic conditions of Example 1, record the chromatogram, and calculate according to the area normalization method. The test results at a wavelength of 274nm are shown in Table 2.

[0075] Table 2 Summary of repeatability test results

[0076]

[0077] The test results of the precision test show that the RSD% of the impurities in the 6 samples of the analysis method of the present invention is less than 5%, and the method has good repeatability.

[0078] 2. Forced degradation test

[...

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Abstract

The invention discloses a high performance liquid chromatography method for separating and detecting related substances in pranoprofen eye drops, which adopts a chromatographic column with octadecylsilane chemically bonded silica as a filler and acetate buffer solution-acetonitrile as a mobile phase for gradient elution, and can quickly and effectively separate the related substances in the pranoprofen eye drops. Comprise process impurities, illumination degradation impurities, oxidative degradation impurities and the like. Compared with the conventional high performance liquid chromatography, the method has the advantages that the analysis time is obviously shortened, the specificity is high, the sensitivity is high, the durability is good, and the operation is simple and convenient.

Description

technical field [0001] The invention belongs to the field of chemical analysis, in particular to a method for detecting related substances of pranoprofen eye drops. Background technique [0002] Pranoprofen, chemical name: (2RS)-2-(10H-9-oxa-1-azaanthracen-6-yl)propionic acid, chemical structural formula: [0003] [0004] Pranoprofen is a non-steroidal anti-inflammatory analgesic drug developed by Welfide Company (formerly Jifu Pharmaceutical Co., Ltd., now Mitsubishi Pharmaceuticals). Senshou Pharmaceutical Co., Ltd. developed it as eye drops and launched it in Japan in 1988. It is clinically used for symptomatic treatment of blepharitis, conjunctivitis, keratitis, scleritis and other inflammations of the outer eye and anterior segment. [0005] There are few reports in the literature on the analysis methods of related substances in pranoprofen eye drops. The Japanese Pharmacopoeia and the Korean Pharmacopoeia have recorded the quality standards for pranoprofen raw ma...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/32G01N30/34G01N30/54G01N30/74
CPCG01N30/02G01N30/06G01N30/32G01N30/34G01N30/54G01N30/74G01N2030/324
Inventor 曹敏王宇刘艳华许梦洁李双阳
Owner HANGZHOU XINBOSI BIOMEDICAL CO LTD
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