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Separation and detection methods for related substances in naphazoline hydrochloride, chlorphenamine maleate and vitamin B12 eye drops

A technology of naphthalene vitamin eye drops and related substances, which is applied in the direction of material separation, measuring devices, and analysis materials, etc., can solve the problems of failing to detect active ingredients vitamins at the same time, and achieve product quality, control, and safety The effect of sex and quality attributes

Inactive Publication Date: 2021-03-23
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

Although the Chinese patent CN201911385569.3 provides a method for detecting related substances in naphthalene eye drops, it can only detect the active ingredients naphazoline hydrochloride and chlorpheniramine maleate in naphthalene eye drops. Related substances, failed to detect the active ingredient vitamin B at the same time 12 related substances

Method used

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  • Separation and detection methods for related substances in naphazoline hydrochloride, chlorphenamine maleate and vitamin B12 eye drops
  • Separation and detection methods for related substances in naphazoline hydrochloride, chlorphenamine maleate and vitamin B12 eye drops
  • Separation and detection methods for related substances in naphazoline hydrochloride, chlorphenamine maleate and vitamin B12 eye drops

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] With Naminwei eye drops as need testing solution, precision measure need testing solution 1.0mL and place in 100mL volumetric flask, add water and dilute to scale, shake up, as need testing control solution (concentration is 1.0%). Precisely measure 100 μL each of the test solution and the control solution of the test, inject them into the Dianne U3000 high-performance liquid chromatograph respectively, and separate according to the following conditions to obtain Figure 3 ~ Figure 8 The high performance liquid chromatogram shown.

[0087] Chromatographic conditions: the chromatographic column is a Thermo Scientific AcclaimTM 120 C18 chromatographic column (250mm×4.6mm, 5 μm); the mobile phase A is 0.07mol / L disodium hydrogen phosphate solution (adjust the pH value to 3.5 with phosphoric acid), and the mobile phase B It is methanol; the column temperature is 25°C.

[0088] Elution conditions: using gradient elution, the elution time and the volume content of mobile pha...

Embodiment 2

[0099] Get naphthalene eye drops as need testing solution, precision measure need testing solution 1.0mL and place in 100mL volumetric flask, add water and dilute to scale, shake up, as need testing control solution (concentration is 1.0%). Precisely measure 50 μL each of the test solution and the control solution of the test, inject them into the Dianne U3000 high-performance liquid chromatograph respectively, and separate according to the following conditions to obtain Figure 9 to Figure 14 The high performance liquid chromatogram shown.

[0100] Chromatographic conditions: the chromatographic column is a Waters XBridge C8 chromatographic column (150mm × 4.6mm, 3.5 μm); the mobile phase A is a 1.2mol / L disodium hydrogen phosphate solution (adjust the pH value to 3.5 with phosphoric acid), and the mobile phase B is Acetonitrile; the column temperature is 30°C.

[0101] Elution conditions: using gradient elution, the elution time and the volume content of mobile phase B in t...

Embodiment 3

[0112] Get naphthalene eye drops as need testing solution, precision measure need testing solution 1.0mL and place in 100mL volumetric flask, add water and dilute to scale, shake up, as need testing control solution (concentration is 1.0%). Precisely measure 100 μL each of the test solution and the control solution of the test, inject them into the Dianne U3000 high-performance liquid chromatograph respectively, and separate according to the following conditions to obtain Figure 15 ~ Figure 20 The high performance liquid chromatogram shown.

[0113] Chromatographic conditions: the chromatographic column is an Endeavorsil C18 chromatographic column (250mm×4.6mm, 5 μm); the mobile phase A is a 0.5mol / L disodium hydrogen phosphate solution (adjust the pH value to 3.5 with phosphoric acid), and the mobile phase B is methanol; The column temperature was 45°C.

[0114] Elution conditions: using gradient elution, the elution time and the volume content of mobile phase B in the mobi...

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Abstract

The invention relates to separation and detection methods for related substances in naphazoline hydrochloride, chlorphenamine maleate and vitamin B12 eye drops, and belongs to the field of pharmaceutical analysis. The separation method comprises the following steps of: injecting the naphazoline hydrochloride, chlorphenamine maleate and vitamin B12 eye drops into a high performance liquid chromatograph, and carrying out separation under the following conditions: a chromatographic column is a C8 or C18 chromatographic column; the mobile phase comprises a mobile phase A and a mobile phase B, themobile phase A is disodium hydrogen phosphate, and the mobile phase B is an alcohol compound and / or acetonitrile; and the elution time and the volume content of the mobile phase B in the elution timeare as follows: 0-25 min, 18%-20%; 25-70 min, 20%-45%; 70-80 min, and 45%; 80-85 min, and 45%-18%. The separation method can be used for separating related substances corresponding to three effectivecomponents in the naphazoline hydrochloride, chlorphenamine maleate and vitamin B12 eye drops. The detection method comprises the following steps of: taking the naphazoline hydrochloride, chlorphenamine maleate and vitamin B12 eye drops as a test solution, preparing reference solutions, respectively carrying out chromatographic detection on the test solution and the reference solutions, and calculating the content of each related substance according to a recorded chromatogram. The detection method can be used for rapidly and accurately detecting the contents of related substances correspondingto the three effective components in the naphazoline hydrochloride, chlorphenamine maleate and vitamin B12 eye drops.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for separating and detecting related substances in Naminwei eye drops. Background technique [0002] Naminwei eye drops are composed of naphazoline hydrochloride, chlorpheniramine maleate, vitamin B 12 It is a compound preparation composed of various excipients and is suitable for treating discomfort symptoms such as eye fatigue, conjunctival hyperemia and eye itching. [0003] Naminwei Eye Drops contains a variety of related substances (impurities). In order to ensure the safety and quality controllability of Naminwei eye drops products, it is necessary to test the content of related substances. At present, the 2020 edition of the "Chinese Pharmacopoeia" does not specify the method for testing its related substances. Although the Chinese patent CN201911385569.3 provides a method for detecting related substances in naphthalene eye drops, it can only detect the a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/14G01N30/32G01N30/34G01N30/54
CPCG01N30/02G01N30/14G01N30/32G01N30/34G01N30/54G01N2030/324
Inventor 王超付欢张晓男刘佩佩胡梦琳郭欢
Owner 湖北远大天天明制药有限公司
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