Method for detecting content of moroxydine hydrochloride in Ganmaoqing capsule
A technology of morpholine guanidine hydrochloride and a detection method, which are applied in the content detection of morpholine guanidine hydrochloride and the content detection of active ingredients in pharmaceutical preparations, can solve problems that affect the accuracy of analysis results, the degree of separation is not ideal, and the morpholine hydrochloride is not specified. Guanidine content determination and other problems, to achieve the effect of linearity retention and stability, good quality, and strong specificity
Inactive Publication Date: 2015-05-13
浙江泰利森药业有限公司
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Problems solved by technology
The current quality standard of Ganmaoqing Capsules only stipulates the content determination of acetaminophen, but does not stipulate the content determination of morpholine hydrochloride
And although there are some relevant bibliographical reports about the content detection method of morpholine guanidine hydrochloride, such as HPLC method simultaneously measures the content of three components in Ganmaoqing Capsules, high performance liquid chromatography simultaneously measures the content of two components in Ganmaoqing Capsules, etc., Including the Chinese invention patent application with the publication number CN103091443A, which discloses a "method for detecting the content of morpholine guanidine hydrochloride and copper acetate in mixed preparations", etc., the mobile phases used include sodium acetate-acetic acid, methanol-water-glacial acetic acid etc., but the resolution of these detection methods is not ideal, which affects the accuracy of the analysis results, and has not been included in the national standard
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[0011] The detection method of morpholine guanidine hydrochloride content in Ganmaoqing capsules of the present invention is measured with reversed-phase high-performance liquid chromatography, and it is reference substance with morpholine guanidine hydrochloride, with triethylamine (adjust pH to 3.0 with phosphoric acid)-acetonitrile (volume The ratio is 80:20) as the mobile phase. Wherein the high-performance liquid chromatography condition is: with octadecylsilane bonded silica gel as filler, 0.05mol / L triethylamine (adjust pH to 3.0 with phosphoric acid)-acetonitrile as mobile phase with a volume ratio of 80:20, The detection wavelength is 237nm, and the number of theoretical plates is not less than 1200 based on the peak of morpholine guanidine hydrochloride. The specific operation steps are as follows:
[0012] 1) Preparation of reference substance solution: Weigh 12 mg of morpholine guanidine hydrochloride reference substance dried to constant weight at 105°C, put it i...
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Abstract
The invention discloses a method for detecting the content of moroxydine hydrochloride in a Ganmaoqing capsule. According to the invention, the determination is performed by adopting reversed-phase high-performance liquid chromatography, using the moroxydine hydrochloride as a contrast, using octadecyl silane bonded silica gel as a filling agent and using triethylamine-acetonitrile with a volume ratio of 80-20 as a mobile phase, wherein a pH value of triethylamine is regulated to 3.0 by using phosphoric acid. The method has the advantages of strong specificity, good precision and repeatability, strong linear preserving property and stability, and the like, and can be used for effectively detecting the content of moroxydine hydrochloride in the Ganmaoqing capsule so as to control the quality of a product and ensure the safety and effectiveness of a medicine preparation.
Description
technical field [0001] The invention relates to a method for detecting the content of active ingredients in pharmaceutical preparations, in particular to a method for detecting the content of morpholine guanidine hydrochloride in traditional Chinese medicine capsule preparations for treating colds, and belongs to the technical field of drug quality control. Background technique [0002] Ganmaoqing Capsule is a traditional Chinese medicine capsule preparation for the treatment of colds. It has the effects of dispelling wind, relieving the exterior, clearing away heat and detoxifying. The prescription is composed of 6 traditional Chinese medicines such as Nanlangen and Daqingye, and three chemical medicines: acetaminophen, morpholine hydrochloride, and chlorpheniramine maleate. The specific preparation methods and uses have been recorded in the revision of national drug standards. The quality standard attached to the approval document (2002ZFB0245). The morpholine hydrochlori...
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IPC IPC(8): G01N30/02
Inventor 文君洪斌韩风崔生法肖亚宝
Owner 浙江泰利森药业有限公司
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