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Method for detecting related substances in procaterol hydrochloride oral solution

A technology for procaterol hydrochloride and related substances, which is applied in the field of detection of related substances in procaterol hydrochloride oral solution, can solve the problems of control, inability to effectively monitor preparation impurities, inability to separate or distinguish, etc., to achieve effective product quality Effect

Active Publication Date: 2020-06-05
北京海泰天正医药科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Only the standard for the active ingredient of Procaterol Hydrochloride Oral Solution was recorded in the import review standard for this preparation, but the relevant substances were not controlled in this standard
[0004] In the 2015 edition of "Chinese Pharmacopoeia", the HPLC method for the detection of related substances in the raw materials of Procaterol hydrochloride was included. In addition, a similar method for the detection of raw materials was also included in the 2017 Japanese Pharmacopoeia, but this method also Inability to isolate or differentiate related substances in oral solutions containing complex ingredients such as preservatives
[0005] In summary, there is still no detection method for related substances in Procaterol Hydrochloride Oral Solution, which cannot effectively monitor the impurities in the preparation, and it is necessary to develop an effective method for the detection of impurities in this variety

Method used

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  • Method for detecting related substances in procaterol hydrochloride oral solution
  • Method for detecting related substances in procaterol hydrochloride oral solution
  • Method for detecting related substances in procaterol hydrochloride oral solution

Examples

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Effect test

preparation example Construction

[0043] (1) Preparation of reference substance stock solution:

[0044] Take Procaterol hydrochloride reference substance, accurately weighed, add water to make it dissolve and dilute to make a solution containing 1 μg per 1ml, as Procaterol hydrochloride reference substance stock solution, take hydrolyzate and aldehyde compound reference substance, accurately weigh, Add methanol separately to dissolve and dilute to make a solution containing 100 μg of each hydrolyzate or aldehyde compound per 1 ml, take an appropriate amount precisely, and dilute with water to make a solution containing 1 μg of each hydrolyzate or aldehyde compound per 1 ml, as a hydrolyzate respectively , aldehyde compound reference substance stock solution;

[0045] (2) Preparation of reference solution, sensitivity solution and blank excipient solution:

[0046] Accurately measure 1ml of each stock solution, put it in a 20ml measuring bottle, dilute to the mark with water, shake well, and as the reference ...

Embodiment 1

[0053] The methanol used in the examples of the present invention is chromatographically pure, and the rest of the medicines are analytically pure, unless otherwise specified.

[0054] 1. Instruments and reagents

[0055] Instruments: Agilent 1200 high performance liquid chromatography (Agilent), BT125D electronic balance (Sartorius Scientific Instrument Co., Ltd.), PHS-3C pH meter (Shanghai Yidian (Lei Magnetic)), KH-500E ultrasonic cleaner (Kunshan Hechuang Ultrasonic Instrument Co., Ltd.);

[0056] Reagent: R-SO 3 Na (R is pentyl), glacial acetic acid, methanol.

[0057] 2. Sample information

[0058] Procaterol hydrochloride working reference substance: the source of raw materials is Tianjin Pharmaceutical Research Institute Pharmaceutical Co., Ltd., calibrated by Beijing Haitai Tianzheng Pharmaceutical Technology Co., Ltd., and the content is expressed in C 16 h 22 N 2 o 3 · HCl is 96.8%;

[0059] Aldehyde compound 8-hydroxy-2-oxo-1,2-dihydroquinoline-5-carbaldehy...

Embodiment 2

[0128] In addition to changing to the hydrophobic salt in mobile phase A, try the detection method suggested in Example 1, the conditions are as follows:

[0129] Chromatographic column: Octadecylsilane bonded silica gel as filler (4.6×250mm, 5μm)

[0130] Mobile phase A: salt solution (R-SO 3 Na (R respectively select C8, C10, C12) 1.0g, add 1000ml of water to dissolve, add 40ml of glacial acetic acid, shake well)-methanol (80:20)

[0131] Mobile Phase B: Methanol

[0132] Gradient elution program:

[0133] time (min) Mobile phase A% Mobile phase B% 0 100 0 5 100 0 40 20 80 41 100 0 50 100 0

[0134] Flow rate: 1.0ml / min

[0135] Column temperature: 40°C

[0136] Detection wavelength: 254nm

[0137] Injection volume: 100 μl.

[0138] Through the comparison of Examples 1 and 2, it can be seen that with the extension of the carbon chain in the hydrophobic salt, the retention time of the main peak and each impurity peak is p...

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Abstract

The invention discloses a method for detecting related substances in a procaterol hydrochloride oral solution, which comprises the following steps: introducing the procaterol hydrochloride oral solution into an octadecylsilane chemically bonded silica column, and performing eluting by controlling the column temperature and flow rate thereof. The eluent is composed of a mobile phase A and a mobilephase B, the mobile phase A is composed of a hydrophobic salt solution and methanol in a fixed volume ratio, and the mobile phase B is methanol. The detection method disclosed by the invention is goodin specificity and high in sensitivity, the system applicability meets the requirements, and a new method is provided for quality control of the procaterol hydrochloride oral solution.

Description

technical field [0001] The invention relates to the detection field of drug impurities, in particular to a detection method for related substances in procaterol hydrochloride oral solution. Background technique [0002] Procaterol hydrochloride is a 5-(1-hydroxy-2-isopropylaminobutyl)-8-hydroxyquinolone hydrochloride hemihydrate, mainly used for bronchial asthma, asthmatic bronchitis, with bronchial reactivity Increased acute bronchitis, chronic obstructive pulmonary disease. As a β2 receptor agonist, Procaterol hydrochloride has high selectivity to the β2 and adrenergic receptors of bronchial smooth muscle, thereby relaxing the bronchial smooth muscle, and at the same time, it is used for anti-allergic effect and promoting airway cilia movement. [0003] Procaterol hydrochloride oral solution is one formulation type of this class of drugs. At present, the relevant standards of this type of preparation are not included in the pharmacopoeias of various countries in the worl...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34
CPCG01N30/02G01N30/06G01N30/34G01N2030/047
Inventor 皮光玉王业香许慧敏靳淑萍
Owner 北京海泰天正医药科技有限公司
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