Phthalic anhydride and detection method for related substances thereof

A technology related to substances and detection methods, applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as the inability to effectively separate known impurities, and achieve the effects of good peak shape, strong specificity and good reproducibility

Inactive Publication Date: 2019-04-09
山东绅联药业股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The main problem of this technical solution is that its related substance method

Method used

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  • Phthalic anhydride and detection method for related substances thereof
  • Phthalic anhydride and detection method for related substances thereof
  • Phthalic anhydride and detection method for related substances thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] (1) Detection conditions

[0037] Instrument: waters e2695 high performance liquid chromatography, 2998PDA detector, detection wavelength: 280nm;

[0038] Chromatographic column: waters Symmetry C8 (250mm×4.6mm, 5μm) chromatographic column;

[0039] Solvent: mobile phase A: potassium dihydrogen phosphate buffer (take 0.61g potassium dihydrogen phosphate, add 1000ml of water to dissolve, adjust the pH value to 2.40 with phosphoric acid); mobile phase B: acetonitrile; volume ratio of mobile phase A to mobile phase B For: 85:15;

[0040] Flow rate: 1.0mL / min

[0041] Column temperature: 35°C;

[0042] Injection volume: 20μL;

[0043] Carry out linear gradient elution according to Table 1.

[0044] Table 1

[0045]

[0046] (2) Detection steps

[0047] Preparation of blank solution: Take 5ml of dimethyl sulfoxide, put it in a 100ml measuring bottle, add 15% acetonitrile water to dilute to the mark, shake well, and use it as a blank solution.

[0048] Preparation ...

Embodiment 2

[0052] According to the similar detection method of Example 1, wherein the concentration of potassium dihydrogen phosphate solution is replaced by 0.55g / L. The spectrum of its mixed reference substance is shown in Figure 4 , The chromatogram of the test product is shown in Figure 5 .

Embodiment 3

[0054] According to the similar detection method of Example 1, wherein the concentration of potassium dihydrogen phosphate solution is replaced by 0.67g / L. The chromatogram of its mixed reference substance is shown in Image 6 , The chromatogram of the test product is shown in Figure 7 .

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Abstract

The invention relates to the technical field of a method for chemical drug analysis, and particularly phthalic anhydride and a detection method for related substances thereof. The detection method ischaracterized in that performing gradient elution on a high-performance liquid chromatograph, the phthalic anhydride peaks in the form of phthalic acid under the condition. The chromatographic condition comprises that: the chromatographic column is an octyl silane bonded silica gel chromatographic column, a potassium dihydrogen phosphate buffer solution is mobile phase A, acetonitrile is mobile phase B, the detection wavelength is 225 to 235 nm, the column temperature is 30 to 37 DEG C, the flow rate is 0.8 to 1.2 mL/min, and gradient elution is performed. The preparation method of the mobilephase A comprises the following steps: taking 0.61 g potassium dihydrogen phosphate; dissolving with water and diluting to 1000 mL; and adjusting the pH value to 2.2 to 2.6 with phosphoric acid. According to the phthalic anhydride and the detection method for the related substances thereof, the phthalic anhydride and the related substances can be effectively separated, the separation degree is good, so that the quality of the phthalic anhydride can be effectively controlled.

Description

(1) Technical field [0001] The invention relates to the technical field of chemical drug analysis methods, in particular to a detection method for phthalic anhydride and related substances. (2) Background technology [0002] As we all know, the impact of drug purity on patients is very large. Impurity of injected drugs is the main cause of adverse drug reactions (such as allergies, drug fever, etc.). Impure oral drugs may increase the incidence of adverse reactions, such as nausea, vomiting, abdominal pain, and diarrhea. At the same time, it may affect the absorption of drugs, thereby affecting the efficacy of drugs. Therefore, the detection method of drug purity is particularly important. Related substances (Telated substances) refer to the starting materials, reagents, intermediates, by-products and other substances brought in during the production of raw materials And special impurities such as degradation products, polymers or crystal transformations generated during ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 董海霞燕禹辛邢科刘建洋甄爱华
Owner 山东绅联药业股份有限公司
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