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HPLC method for detection of octylated diphenylamine in lansoprazole

A technology for detection of octylated diphenylamine and its detection method, which is applied in the field of HPLC detection of octylated diphenylamine, can solve problems such as unseen and affecting the safety of the main drug, and achieve simple operation, low cost and high precision Effect

Active Publication Date: 2017-10-17
CHENGDU BAIYU JINGELAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, during the contact process of the packaging material with the main drug, some specific components (such as: sulfur, phenol, octylated diphenylamine, etc.) will penetrate into the main drug under certain conditions, which will affect the safety of the main drug in clinical use.
However, there have been no relevant reports

Method used

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  • HPLC method for detection of octylated diphenylamine in lansoprazole
  • HPLC method for detection of octylated diphenylamine in lansoprazole
  • HPLC method for detection of octylated diphenylamine in lansoprazole

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] 1. Determination of detection wavelength

[0040] Accurately weigh an appropriate amount of lansoprazole, and use mobile phase (methanol-water=25:75) to prepare a solution with a concentration of 20 μg / mL as the test solution.

[0041] Accurately weigh an appropriate amount of the reference substance (octylated diphenylamine), and use mobile phase (methanol-water=25:75) to prepare a solution with a concentration of 20 μg / mL as the reference substance solution.

[0042] Take the above-mentioned test solution and reference solution, and scan in the wavelength range of 200nm to 400nm. The test results are shown in Table 1.

[0043] Table 1, the ultraviolet scanning result of the present invention

[0044] project

Peak wavelength(nm)

the peak

Valley wavelength(nm)

valley

Test solution

211

0.721

240

0.001

Reference solution

210

0.865

272

0.005

[0045] The test results show that the detection wavel...

Embodiment 2

[0073] Chromatographic column filler: octadecylsilane bonded silica gel is used as the filler;

[0074] The model of the chromatographic column is Waters Xbridge shield RP18, the specifications are: the inner diameter is 4.6mm, the length is 50mm, and the filler particle size is 5μm;

[0075] Mobile phase: methanol-water (volume ratio 25:75);

[0076] Column temperature: 40°C;

[0077] Flow rate: 1.0mL / min;

[0078] Detection wavelength: 210nm;

[0079] Injection volume: 20 μL.

[0080] Carry out interference test according to the method for embodiment 1, the result shows: the degree of separation between lansoprazole (retention time is 0.575min) and octylated diphenylamine reference substance (retention time is 25.935min) is 21.123, theoretical plate The number (calculated according to the octylated diphenylamine chromatographic peak) is 49315, and the tailing factor is 0.999.

[0081] It can be seen that the chromatographic conditions can accurately detect the content o...

Embodiment 3

[0083] Detection by reversed-phase high-performance liquid chromatography:

[0084] Chromatographic column filler: octadecylsilane bonded silica gel is used as the filler;

[0085] The model of the chromatographic column is Waters Xbridge shield RP18, the specifications are: the inner diameter is 4.6mm, the length is 50mm, and the filler particle size is 5μm;

[0086] Mobile phase: methanol-water (20:80 by volume);

[0087] Column temperature: 40°C;

[0088] Flow rate: 1.0mL / min;

[0089] Detection wavelength: 210nm;

[0090] Injection volume: 20 μL.

[0091] Carry out system suitability test according to the method for embodiment 1, the result shows: the degree of separation between lansoprazole (retention time is 1.207min) and octylated diphenylamine reference substance (retention time is 29.965min) is 25.723, theoretical The number of plates (calculated according to the octylated diphenylamine chromatographic peak) is 41278, and the tailing factor is 0.992.

[0092] I...

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Abstract

The invention discloses an HPLC (high-performance liquid chromatography) detection method for octylated diphenylamine in lansoprazole. A test proves that octylated diphenylamine in lansoprazole can be separated and detected, a detection result is accurate and reliable, and the detection method has the advantages of excellent linear relationship, high precision, good stability, good repeatability, high recovery rate, simplicity and convenience in operation, low cost and the like, can effectively monitor the quality of lansoprazole for injection and is suitable for popularization and application.

Description

technical field [0001] The invention relates to an HPLC detection method of octylated diphenylamine in lansoprazole. Background technique [0002] Lansoprazole (Lansoprazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]-sulfinyl]-1H-benzene And imidazole, molecular formula: C 16 h 14 f 3 N 3 o 2 S, molecular weight: 369.37) is a proton pump inhibitory drug, which can selectively inhibit the ATPase of gastric parietal cells, and is an anti-ulcer drug that inhibits gastric acid secretion. It can inhibit Helicobacter pylori, protect and promote the healing of gastric mucosal ulcers. Hypersecretion of gastric acid caused by various reasons has a good effect. [0003] [0004] Lansoprazole for Injection is one of the most common Lansoprazole products. It is usually packaged in a controlled glass injection and a bromobutyl rubber stopper. However, during the contact process of the packaging material with the main drug, some specific components (such as: sul...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88G01N30/06
CPCG01N30/06G01N30/88
Inventor 宋务雄孙毅
Owner CHENGDU BAIYU JINGELAI PHARMA CO LTD
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