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A kind of content detection method of alprostadil injection

A technology of dier injection and alprostadil, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problem of β-naphthol peak area reduction, improve detection precision, and solve the problem of internal standard β-naphthol The effect of reducing the area of ​​phenol peak and improving the precision of injection

Active Publication Date: 2016-10-05
SHANGHAI JINGFENG PHARMA
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Problems solved by technology

[0007] The object of the present invention is to provide a kind of content detection method of alprostadil injection, to overcome the weak point in the above-mentioned detection method, this method detection is accurate, effectively solved the internal standard substance β in the content detection of alprostadil injection - The problem of reduced peak area of ​​naphthol

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  • A kind of content detection method of alprostadil injection

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Embodiment 3

[0035] A kind of content detection method of alprostadil injection, the steps are: prepare β-naphthol internal standard solution; Need testing solution and reference substance solution are prepared into the β-naphthol internal standard solution containing identical concentration, then, adopt Alprostadil is separated by column by high performance liquid chromatography, and the post-column derivatization method is used as the reaction solution in 1mol / L KOH solution, and the temperature of the reaction pool is 60°C. Finally, alprostadil and β -Naphthol peak area, calculate alprostadil content with internal standard method.

[0036] The preparation method of β-naphthol internal standard solution is to take 25mg of β-naphthol, accurately weigh it, put it in a 50ml measuring bottle, add absolute ethanol to dissolve and dilute to the scale, measure 5ml, put it in a 50ml measuring bottle, add methanol to dilute To the mark, shake well, as the first solution; take 5ml of the first sol...

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Abstract

The invention relates to a content detection method of an alprostadil injection. The content detection method of the alprostadil injection comprises the following steps: preparing a beta-naphthol internal standard solution; preparing beta-naphthol internal standard solutions with the same concentration from a test solution and a reference solution, then carrying out column separation on alprostadil by using a high performance liquid chromatography, taking 1 mol / L of a KOH solution as a reaction solution by using a post-column derivatization method, controlling the temperature of a reaction tank to be 60 DEG C, finally detecting alprostadil and beta-naphthol peak area on a wavelength of 278 nm, and calculating the content of alprostadil by using an internal standard method. By adopting the method provided by the invention to detect the content of the alprostadil injection, the problem of small beta-naphthol peak area in the existing method for detecting the content of the alprostadil injection is effectively solved, the detection accuracy of the content of the alprostadil injection is improved, and the content detection method of the alprostadil injection is applicable to detection of the content of the alprostadil injection in different prescriptions.

Description

Technical field: [0001] The invention relates to a method for detecting the content of alprostadil injection. Background technique: [0002] Alprostadil is also known as prostaglandin E1, English name: PROSTAGLANDIN E1, English abbreviation PGE1, chemical name: (1R,2R,3R)-3-hydroxyl-2(E)-(3S)-3-hydroxyl-1-octyl Alkenyl-5-oxocyclopentaneheptanoic acid, molecular formula: C 20 h 34 o 5 , molecular weight: 354.49. The structural formula is as follows: [0003] [0004] For the content analysis method of alprostadil injection, it is comparatively common to use HPLC method to cooperate post-column derivatization at present, use the phosphate buffer solution and acetonitrile (3:1) that pH value is 6.0 as mobile phase and dilute constant volume β- Naphthol internal standard solution and prostadil reference substance solution, because phosphate buffer saline is mixed with acetonitrile (3:1) with mobile phase, some lipophilic substances in alprostadil injection prescription c...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 叶湘武邱永锋刘华付爱玲
Owner SHANGHAI JINGFENG PHARMA
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