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A kind of detection method of aripiprazole related substance

A technology for the detection of aripiprazole and its detection method, which is applied in the field of drug quality detection, can solve the problems such as the separation degree between the main component and each impurity not meeting the requirements, the damage of the chromatographic column, and the impurity cannot be detected, etc. The effect of good tail factor and small risk

Active Publication Date: 2022-05-13
YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] ChP is detected by high-performance liquid chromatography system, in which citrate buffer-acetonitrile isocratic elution is used. This method has more salt phases, and ion-pairing reagents are used at the same time, which will cause greater damage to the chromatographic column, and the sensitivity is too low. 0.1% impurity cannot be detected
[0005] The BP method and EP9.0 method are the same as the USP41 method. They all adopt high-performance liquid chromatography system, in which 0.05% trifluoroacetic acid and acetonitrile are used for gradient elution, and trifluoroacetic acid has great damage to the chromatographic column. The degree of separation from each impurity does not meet the requirements

Method used

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  • A kind of detection method of aripiprazole related substance
  • A kind of detection method of aripiprazole related substance
  • A kind of detection method of aripiprazole related substance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] Utilize ultraviolet-visible spectrophotometer to carry out full-wavelength scanning to aripiprazole and each impurity, obtained result is as follows figure 1 As shown, wherein (a) is the peak-out situation of each impurity and main component in the system suitability solution (preparation method is shown in (2)), and the order of peak-out is EP impurity A, EP impurity B, EP impurity D, EP impurity C, isomer impurity, EP impurity E, aripiprazole, EP impurity F, intermediate I, unknown impurity 1 in the test product, unknown impurity 2 in the test product and EP impurity G, (b) is Full-wavelength scanning results, from top to bottom are EP impurity A, EP impurity B, EP impurity D, EP impurity C, isomer impurities, EP impurity E, (c) is the full-wavelength scanning results, from top to bottom Aripiprazole, EP impurity F, intermediate impurity, unknown impurity 1 in the test product, unknown impurity 2 in the test product and EP impurity G; figure 1 It shows that both arip...

Embodiment 2

[0100] Durability test:

[0101] The preparation method of system suitability solution is identical with embodiment 1;

[0102] The detection wavelength in the reversed-phase high-performance liquid chromatography condition is respectively set to be 249nm and 259nm, and other conditions are consistent with embodiment 1, and the system suitability solution is carried out reversed-phase high-performance liquid chromatography detection, and gained spectrogram is as follows Figure 7 ~ Figure 8 shown;

[0103] Flow rate is set to be 0.9mL / min and 1.1mL / min in the reversed-phase high-performance liquid chromatography condition respectively, and other conditions are consistent with embodiment 1, and system suitability solution is carried out reversed-phase high-performance liquid chromatography detection, and gained spectrogram is as follows Figure 9 ~ Figure 10 shown;

[0104] The temperature of the chromatographic column in the reversed-phase high-performance liquid chromatogra...

Embodiment 3

[0108] Solution stability testing:

[0109] The preparation method of need testing solution, 1% self control solution and system suitability solution is identical with embodiment 1, respectively the 0h, 2h, 4h, 8h, 12h, 16h, 24h, 32h and 48h to system suitability solution Reverse-phase high-performance liquid chromatography detection; respectively at 0h, 3h, 7h, 11h, 15h, 23h and 33h for reverse-phase high-performance liquid chromatography detection of the test solution; respectively at 0h, 3h, 7h, 11h, 15h , 23h and 38h carry out reversed-phase high-performance liquid chromatography to 1% self control solution and detect detection condition and embodiment 1 identically, the obtained result table 3~shown in table 5:

[0110] Table 3 System Suitability Solution Stability Test Results

[0111] point in time EP-A EP-B EP-D EP-C YGT EP-E EP-F M1 EP-G 0h 100.00％ 100.00％ 100.00％ 100.00％ 100.00％ 100.00％ 100.00％ 100.00％ 100.00％ 2h 99.93％ ...

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Abstract

The invention relates to the technical field of drug quality detection, and provides a method for detecting related substances of aripiprazole. The invention uses reversed-phase high-performance liquid chromatography for detection, and calculates the content of related substances of aripiprazole through self-control method ; The detection method provided by the invention prepares each solution with methanol-acetonitrile-water-glacial acetic acid mixed solvent, and the blank solvent will not interfere with the determination of related substances; use potassium dihydrogen phosphate buffer solution-methanol-acetonitrile as mobile phase to carry out gradient elution , Potassium dihydrogen phosphate is less dangerous, it is convenient for experimenters to operate, the mobile phase is easy to obtain and has less damage to the chromatographic column, and good separation can be achieved between impurities and between impurities and main components; the detection method provided by the invention is exclusively Good performance, good durability, can accurately detect the known impurities of aripiprazole, and the resolution of each peak, the number of theoretical plates and the tailing factor are all good. Compared with the current pharmacopoeia method, it can detect the related substances of aripiprazole more conveniently and quickly.

Description

technical field [0001] The invention relates to the technical field of drug quality detection, in particular to a method for detecting related substances of aripiprazole. Background technique [0002] Aripiprazole is a new type of atypical antischizophrenia drug, which has a bidirectional regulation effect on the DA nervous system and is a stabilizer of DA transmitters. It has high affinity with D2, D3, 5-HT1A and 5-HT2A receptors. It produces anti-schizophrenia effect through partial agonism on D2 and 5-HT1A receptors and antagonism on 5-HT2A receptors. [0003] Combined with the synthesis process of aripiprazole, it can be known that the following impurities (ie related substances of aripiprazole) usually exist in aripiprazole: aripiprazole impurity A, impurity B, impurity C, impurity D, impurity E, impurity F, Impurity G, isomer impurities and intermediate impurities. ChP (Chinese Pharmacopoeia), USP (United States Pharmacopoeia), BP (British Pharmacopoeia) and EP (Eur...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/89G01N30/34
CPCG01N30/89G01N30/34
Inventor 徐润贾玉荣卓敏
Owner YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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