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Analysis method for determining low-content sodium metabisulfite in sustained-release pharmaceutical preparation

A sodium pyrosulfite and slow-release drug technology, applied in the field of analysis, can solve problems affecting the extraction of sodium pyrosulfite, and achieve the effects of convenient analysis, high sensitivity and rapid analysis

Inactive Publication Date: 2019-08-20
NOVAST LABORATORIES (CHINA) LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This colorimetric method has good specificity and high sensitivity, but it is only suitable for injections and simple compound preparations. For sustained-release preparations containing polymers such as hypromellose, the process of preparing samples by this method is hypromellose. Polymers such as methyl cellulose are easy to form gel, which affects the extraction of sodium metabisulfite

Method used

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  • Analysis method for determining low-content sodium metabisulfite in sustained-release pharmaceutical preparation
  • Analysis method for determining low-content sodium metabisulfite in sustained-release pharmaceutical preparation
  • Analysis method for determining low-content sodium metabisulfite in sustained-release pharmaceutical preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Determination of sodium metabisulfite content in pramipexole hydrochloride sustained-release tablets (specification: 0.375mg):

[0022] The theoretical content of sodium metabisulfite in the tablet is 0.92 mg, accounting for 0.4% of the entire tablet weight.

[0023] (1) Apparatus and conditions:

[0024] Liquid chromatograph: Agilent 1200 chromatography system and workstation in the United States;

[0025] Chromatographic column: Japan Showa sugar column, SH1011, column length 300 mm, inner diameter 8.0 mm;

[0026] Flow rate: 1.0 ml per minute;

[0027] Detection wavelength: UV 200 nm;

[0028] Injection volume: 50µL;

[0029] Column temperature: 50 ℃;

[0030] Analysis time: 16 minutes.

[0031] (2) Experimental steps:

[0032] Preparation of mobile phase (0.01 N sulfuric acid):

[0033] Weigh 0.3 ml of sulfuric acid and dissolve it in 1 liter of water and shake it well.

[0034] Preparation of test solution:

[0035] Transfer about 5 pramipexole hydrochloride sustained-release tablets...

Embodiment 2

[0046] Determination of sodium metabisulfite content in pramipexole hydrochloride sustained-release tablets (specification: 0.375mg):

[0047] The theoretical content of sodium metabisulfite in the tablet is 0.46 mg, accounting for 0.2% of the entire tablet weight.

[0048] (1) Apparatus and conditions:

[0049] Liquid chromatograph: Agilent 1200 chromatography system and workstation in the United States;

[0050] Chromatographic column: Japan Showa sugar column, SH1011, column length 300 mm, inner diameter 8.0 mm;

[0051] Flow rate: 1.0 ml per minute;

[0052] Detection wavelength: UV 200 nm;

[0053] Injection volume: 50µL;

[0054] Column temperature: 50 ℃;

[0055] Analysis time: 16 minutes.

[0056] (2) Experimental steps:

[0057] Preparation of mobile phase (0.01 N sulfuric acid):

[0058] Weigh 0.3 ml of sulfuric acid and dissolve it in 1 liter of water and shake it well.

[0059] Preparation of test solution:

[0060] Transfer about 5 pramipexole hydrochloride sustained-release tablets...

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Abstract

The invention discloses an analysis method for determining low-content sodium metabisulfite in a sustained-release pharmaceutical preparation. The analysis method comprises the steps of firstly putting a to-be-determined sustained-release tablet into a volumetric flask, then adding an organic solvent such as methanol for ultrasonic disintegration, making up the volume to a scale by a mixed solution of the organic solvent (the methanol) and water, and carrying out centrifuging to obtain supernate as a test product for analysis; analyzing the test product by adopting a liquid chromatography method, and starting a chromatographic acquisition computer system to acquire data; and taking a sodium metabisulfite reference product, using the mixed solution of the organic solvent (the methanol ) andthe water to prepare a reference solution, carrying out liquid chromatography analysis, and then calculating the content of the sodium metabisulfite in the sustained-release tablet. The method has the advantages of being high in specificity, rapid in analysis, high in anti-interference performance and high in sensitivity.

Description

Technical field [0001] The invention specifically relates to an analysis method, which can quickly and conveniently determine the low content of sodium metabisulfite in sustained-release pharmaceutical preparations. Background technique [0002] As an antioxidant, sodium metabisulfite is used in oral, injection and topical preparations. For the determination of pure sodium metabisulfite, the pharmacopeia uses a titration method. For example, in the Chinese Pharmacopoeia 2015, the content of sodium metabisulfite is determined by redox reaction of sodium metabisulfite and iodine solution, and the remaining iodine is sodium thiosulfate Perform a titration and calculate the amount of sodium thiosulfate based on the iodine consumed. This method has poor specificity, low sensitivity, and requires a large sample volume, which is only suitable for constant analysis of pure products. In addition, there are reports in the literature based on the SO released by sodium metabisulfite in aci...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 王海霞钱云冯吉娟朱金燕吉钰房杏春张国华
Owner NOVAST LABORATORIES (CHINA) LTD
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