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Separation and detection method of lansoprazole nitrogen oxide impurities

A technology for the separation of lansoprazole nitrogen oxides and methods, applied in the field of pharmaceutical analysis, can solve problems such as difficult to distinguish peak signals, inability to separate and detect nitrogen oxide impurities, and inability to reflect the purity of the main peak, so as to achieve improved separation and accurate purity Effect

Pending Publication Date: 2022-02-18
广州隽沐生物科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But because there is only one sulfone difference between the structural formula of lansoprazole nitrogen oxide impurity and lansoprazole impurity A, according to the electron cloud distribution situation on the structure, it can be seen that the polarity of the two is very close, obtained by the pharmacopoeia detection method The chromatogram, the peak signal of lansoprazole impurity A and lansoprazole nitrogen oxide impurity is difficult to distinguish, thus can't reflect the true main peak purity, and then can't obtain the purity of accurate lansoprazole
[0004] Therefore, for the above-mentioned related technologies, the inventor thinks that the pharmacopoeia standard method cannot effectively separate and detect the nitrogen oxide impurity that lansoprazole impurity A produces

Method used

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  • Separation and detection method of lansoprazole nitrogen oxide impurities
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  • Separation and detection method of lansoprazole nitrogen oxide impurities

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] This example discloses the separation and detection method of rryazole oxide impurities.

[0041] A moisture mixed-like (commercially available) of about 10 mg is about 10 mg of methacolic acid, which is dissolved and diluted to the scale of methanol-water (60:40) solution in a 20 ml amount bottle. 10 μl of injection of octadecyl silica biless silica gel as a column (specification: 4.6 mm × 250 mm, 5 μm), with methanol to flow phase A, with volume ratio (100: 440: 4.4: 0.9) The methanol-water-triethylamine-phosphoric acid solution is a mobile phase B, and the pH is adjusted to 7.1 with a phosphoric acid solution (1 → 10), the detection wavelength is 284 nm, the injection volume is 5 μL, the column temperature is 35 ° C, according to Table 1 Shuttling is eluted.

[0042] Table 1

[0043]

[0044] Observing HPLC map, see figure 1 : The retention time of Lamovazole impurities A is 10.356 min, and the retention time of Lamovazole nitrogen oxide impurities is 11.787 min.

Embodiment 2

[0046] This example discloses the separation and detection method of rryazole oxide impurities.

[0047]The difference from Embodiment 1 is that the elution gradient is Table 2.

[0048] Table 2

[0049]

[0050] Observing HPLC map, see figure 2 : The retention time of Lan Solarazole impurities A is 5. minutes, and the retention time of Lamovazole nitrogen oxide impurities is 6.231 min.

Embodiment 3

[0052] This example discloses the separation and detection method of rryazole oxide impurities.

[0053] The difference from Example 1 is that the elution gradient is Table 3.

[0054] table 3

[0055]

[0056] Observing HPLC map, see image 3 : The retention time of Lamovazole impurities A is 9.138 min, and the retention time of the Lamovazole nitrogen oxide impurities is 10.400 min.

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Abstract

The invention relates to the field of pharmaceutical analysis, and particularly discloses a separation and detection method of lansoprazole nitrogen oxide impurities. According to the separation and detection method of the lansoprazole nitrogen oxide impurity, octadecylsilane chemically bonded silica is used as a stationary phase, a contrast sample is detected by adopting reversed-phase high-performance liquid chromatography, the sum of volume ratios of a mobile phase A and a mobile phase B is 100%, the polarity of the mobile phase is greater than that of the stationary phase, the mobile phase A is methanol, a mobile phase B is a methanol-water-triethylamine-phosphoric acid solution with the volume ratio of 100: (440-550): (4.4-6.0): (0.9-2), and elution is carried out according to a specific elution ratio. The method has the advantages that the peak appearance time is moderate, the retention time difference between the impurity A and the nitrogen oxide impurity is large, a real main peak can be reflected, the accurate purity of the lansoprazole is obtained, the technical vacancy of lansoprazole nitrogen oxide impurity detection is filled, and the method has profound significance on quality control of lansoprazole.

Description

Technical field [0001] The present application relates to the field of drug analysis, and more particularly, it relates to the separation and detection method of rryazole oxide impurities. Background technique [0002] Lan Solarazole impurities A (C 16 Hide 14 Fly 3 N 3 O 3 S) is a class of antic acid, structural formula It is a proton pump inhibitor, one of the most effective drugs that inhibit gastric acid secretion, which is a drug for digestive ulcer, reflux of esophageal inflammation, and treatment as an anti-acid drug combined with other drugs. Inductation is gastric ulcer, duodenal ulcer, reflux esophagitis, and Lamoxazole impurities A mainly sold in the world in the form of a tablet, is an effective, tolerated drug. [0003] Lan Solazole impurities A produces different impurities during production, one is a lozolazole impurity A impurity A (C 16 Hide 14 Fly 3 N 3 O 3 S), the structural formula is Another impurities of Lansolazole nitrogen oxide impurities (C 16 Hide 14 ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/34
CPCG01N30/02G01N30/34
Inventor 张洁枝赖金强莫敏芳陈淑韵易嘉辉巫珮珮
Owner 广州隽沐生物科技股份有限公司
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