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A kind of detection method of naphthalene disulfide ethyl lactocholamine raw material or its preparation related substances

A naphthalene disulfide ethyl lactocholesterol and detection method technology, which is applied in the direction of measuring devices, material separation, and analysis materials, can solve the problems of method specificity and sensitivity that cannot meet quality control, and achieve consistent response, stable baseline, and general use good sex effect

Active Publication Date: 2020-05-05
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the relevant literature on the analysis method of naphthalene disulfide ethyl lactoammonium raw material or its preparation is only the dissolution analysis method recorded in the Japanese Orange Book. This method uses an ultraviolet detector for detection and does not involve the detection of impurities. Even in this Optimized on the basis of the method, the specificity and sensitivity of the optimized method still cannot meet the needs of quality control

Method used

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  • A kind of detection method of naphthalene disulfide ethyl lactocholamine raw material or its preparation related substances
  • A kind of detection method of naphthalene disulfide ethyl lactocholamine raw material or its preparation related substances
  • A kind of detection method of naphthalene disulfide ethyl lactocholamine raw material or its preparation related substances

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Detection of Related Substances of Three Batches of Naphthalenedisulfoacetate Cholesterol Raw Drugs

[0040] Get an appropriate amount of this product, dissolve and dilute with a diluent (mobile phase A) to make a solution containing about 10 mg in every 1 ml, as the test solution; accurately measure an appropriate amount of the test solution, and quantitatively dilute with a diluent to make each 1ml containing about 10μg of the solution, as a control solution.

[0041] Thermo Fisher UltiMate3000DGLC high performance liquid chromatography was used, with octadecylsilane bonded silica gel as filler (Waters Atalantis T3, 4.6×250mm, 5μm), column temperature was 25°C; flow rate was 1.0ml / min; detector It is a charged aerosol detector, and the detector temperature is 50°C;

[0042] The related substances were 0.1% pentafluoropropionic acid aqueous solution as mobile phase A, methanol as mobile phase B, gradient elution in the following table, and reverse gradient post-column...

Embodiment 2

[0049] Detection of Related Substances in Two Batches of Naphthalenedisulfoacetate Capsules

[0050] Get an appropriate amount of this product, dissolve and dilute with diluent (mobile phase A) and make the solution that contains about 10mg naphthalene disulfide ethyl lactocholesterol in every 1ml, as need testing solution; The diluent was quantitatively diluted to make a solution containing about 50 μg of naphthalenedisulfame in 1ml, which was used as a control solution.

[0051] Thermo Fisher UltiMate3000DGLC high performance liquid chromatography was used, with octadecylsilane bonded silica gel as filler (Waters Atalantis T3, 4.6×250mm, 5μm), column temperature was 25°C; flow rate was 1.0ml / min; detector It is a charged aerosol detector, and the detector temperature is 50°C;

[0052] The related substances were 0.1% pentafluoropropionic acid aqueous solution as mobile phase A, methanol as mobile phase B, gradient elution in the following table, and reverse gradient post-co...

Embodiment 3

[0058] Methodological validation of chromatographic methods:

[0059] 1. Naphthalene disulfide ethyl lactocholesterol raw material and its capsule related substances location test

[0060] According to the method of embodiment 1 and embodiment 2, prepare respectively naphthalene disulfide ethyl lactocholine raw material and its capsule each related substance reference substance solution, naphthalene disulfo ethyl lactocholine raw material and its capsule and each related substance mixed solution, inject respectively Liquid chromatograph, record the chromatogram. See the table below for the results of separation between the peak of the active ingredient ethyl lactocholamine and the impurities, and see the spectrum figure 2 :

[0061]

[0062] The results showed that the peaks of naphthalene disulfone ethyl lactocholine raw material or its capsules could be well separated from the related substances and the related substances.

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Abstract

The invention discloses a detection method of related substances in aclatonium napadisilate raw materials or preparations thereof. The method comprises following steps: a reversed-phase high-performance liquid chromatography adopting a countergradient column post-compensation mode is adopted, octadecylsilane chemically bonded silica is taken as a packing material for a chromatographic column, a CAD (charged aerosol detector) is adopted, and a flow phase of a reagent is eluted with volatile negative ions. The detection method has high specificity and sensitivity, has higher precision and accuracy and good durability, is applicable to inspection and quality control of related substances in the aclatonium napadisilate raw materials or preparations thereof, can accurately reflect the content of the related substances in aclatonium napadisilate raw materials or preparations thereof and provides a reasonable basis for formulation of quality standards, so that the quality of products is better controlled and mastered, and the safety of clinical medication is improved.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a method for detecting related substances of naphthalene disulfide ethyl lactocholesterol raw material or its preparation. Background technique [0002] Gastric motility drugs have been used clinically for more than 40 years. Metoclopramide (metoclopramide) came out in the 1960s. It has the effect of promoting gastrointestinal motility and antiemetic, and its curative effect is definite. However, metoclopramide can cause extrapyramidal Department of adverse reactions. Subsequent morphine is a peripheral dopamine receptor antagonist, which is characterized by less side effects in the central nervous system. Effect, low oral bioavailability. In the 1980s, Cisapride, which was listed by Janssen Company, is a derivative of toluamide, and its action site is the 5-HT4 receptor located in the cholinergic interneurons and the motor neurons of the myenteric plexus. Th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/89
CPCG01N30/89
Inventor 杨书明徐镜人蔡伟陈凤琴张雪瑜栾芳刘景龙李浩冬
Owner YANGTZE RIVER PHARM GRP CO LTD