Analysis method for determining hydromorphone hydrochloride bulk drug element impurities

A technology for hydromorphone hydrochloride and elemental impurities is applied in the analysis field of determining the elemental impurities of hydromorphone hydrochloride crude drug, can solve problems such as development and research of an elemental impurity analysis method without hydromorphone hydrochloride crude drug, and achieves easy operation, The effect of reducing the acid rush temperature and reducing the signal drift

Pending Publication Date: 2020-04-10
YICHANG HUMANWELL PHARMA
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Problems solved by technology

[0015] In the prior art, there is no research on the development and research of element impurity analysis methods for hydromorphone hydrochloride raw materials

Method used

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  • Analysis method for determining hydromorphone hydrochloride bulk drug element impurities
  • Analysis method for determining hydromorphone hydrochloride bulk drug element impurities
  • Analysis method for determining hydromorphone hydrochloride bulk drug element impurities

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Embodiment 1

[0046] An analytical method for measuring elemental impurities of hydromorphone hydrochloride crude drug, said method comprising the following steps:

[0047] 1. Preparation of diluent (2% nitric acid solution-2% hydrochloric acid solution): accurately measure 1mL of electronically pure grade nitric acid, and set the volume to 500mL with ultrapure water; Fill it into a 500mL volumetric flask [the volumetric flask is made of polyethylene terephthalate (PET), the same below]. Mix the above two solutions 1:1 evenly.

[0048] 2. Preparation of gold standard solution (10μg / mL): Pipette 0.5ml gold single element standard solution (1000μg / mL) [The manufacturer is the National Nonferrous Metals and Electronic Materials Analysis and Testing Center, and the single element standard solutions below are all here Manufacturer] in a 50ml graduated volumetric flask, dilute with ultrapure water and set the volume to the 50ml mark, and shake well.

[0049] 3. Preparation of standard solution ...

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Abstract

The invention relates to an analysis method for determining hydromorphone hydrochloride bulk drug element impurities. The method comprises the steps of system applicability, standard curve preparation, internal standard solution preparation, sample preparation and standard recovery sample preparation, and standard curve drawing, detection limit, sample, and standard recovery rate detection. According to the method, the simultaneous determination of seven elements is split into simultaneous determination of six metal elements, namely arsenic, cadmium, lead, cobalt, nickel and vanadium and independent determination of mercury (Hg); the acid removing temperature is reduced from 150 DEG C to 130 DEG C, the problem that the recovery rate of the mercury element does not reach the standard is solved, the recovery rate can be increased to about 90%; and interference of the mercury (Hg) element on other elements due to the strong memory effect can be reduced through independent measurement. Germanium, indium, bismuth and scandium internal standards are selected, so that the influence of signal drift and matrix effect on measurement can be effectively reduced.

Description

technical field [0001] The invention belongs to the technical field of element impurity analysis of hydromorphone hydrochloride, and in particular relates to an analysis method for determining the element impurity of hydromorphone hydrochloride crude drug. Background technique [0002] "Chinese Pharmacopoeia" contains a variety of methods for the determination of elemental impurities in the four general rules, each of which has different characteristics and certain applicability. Including but not limited to atomic absorption spectrophotometry, inductively coupled plasma mass spectrometry (ICP-MS) and the like. ICP-MS is a mass spectrometry elemental analysis method using plasma as the ion source. It is mainly used for the simultaneous determination of multiple elements. During the measurement, the sample is introduced into the atomization system by the carrier gas (argon gas) for atomization, and then enters the central area of ​​the plasma in the form of aerosol, and is d...

Claims

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Application Information

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IPC IPC(8): G01N27/62G01N1/38G01N1/44G01N27/626
CPCG01N27/62G01N1/38G01N1/44
Inventor 王庆敏李丽娥符义刚田军张瑞娟张丽娜尹振英罗潇潇
Owner YICHANG HUMANWELL PHARMA
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