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Method for detecting high performance liquid chromatography of isomer in irinotecan hydrochloride injection

A kind of technology of irinotecan hydrochloride, detection method

Pending Publication Date: 2020-01-17
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] At present, there are no national standards, other national pharmacopoeias, and literatures to record the chromatographic analysis method of irinotecan hydrochloride injection isomers, so a chromatographic analysis method suitable for irinotecan hydrochloride injection isomers is developed. The quality control of Linotecan injection is of great significance

Method used

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  • Method for detecting high performance liquid chromatography of isomer in irinotecan hydrochloride injection
  • Method for detecting high performance liquid chromatography of isomer in irinotecan hydrochloride injection
  • Method for detecting high performance liquid chromatography of isomer in irinotecan hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Detection conditions:

[0067] Instrument: Waters 2695, Waters 2489 UV detector

[0068] Column: IC (5μm, 4.6×250mm) chiral chromatography column

[0069] Mobile phase: methanol-absolute ethanol-n-hexane-diethylamine (100:100:20:0.2)

[0070] Flow rate: 1.8mL / min

[0071] Column temperature: 35°C

[0072] Injection volume: 25μL

[0073] Detection wavelength: 370nm

[0074] Experimental steps:

[0075] Diluent preparation: 0.05% phosphoric acid in absolute ethanol

[0076] Take about 20mg of irinotecan hydrochloride trihydrate reference substance in a 100mL measuring bottle, take the diluent prepared above, add to about 2 / 3 volume of the measuring bottle, dissolve it by ultrasonic, dilute to the mark with the diluent, shake well, and use as stock solution-1.

[0077] Take about 5.4mg of irinotecan hydrochloride trihydrate isomer reference substance in a 25mL measuring bottle, add diluent to about 2 / 3 volume of the measuring bottle, dissolve it by ultrasonic, di...

Embodiment 2

[0081] Take about 20mg of irinotecan hydrochloride trihydrate reference substance in a 100mL measuring bottle, use 0.05% phosphoric acid in absolute ethanol as the diluent, add the diluent to about 2 / 3 volume of the measuring bottle, ultrasonically dissolve it, and use the diluent Dilute to the mark, shake well, and use as the stock solution of the test substance. Take 4.0mL of the stock solution of the test product to a 250mL measuring bottle, dilute to the mark with diluent, shake well, and use it as the test solution.

[0082] Accurately measure 25 μ L of need testing solution, detect and analyze by the detection condition of embodiment 1, see Figure 4 .

[0083] Figure 4 It showed that no isomer was detected in the test product.

Embodiment 3

[0085] Get irinotecan hydrochloride injection (prepared according to CN109908077A embodiment 1) 2mL in 100mL measuring bottle, take the dehydrated ethanol solution of 0.05% phosphoric acid as diluent, dilute to scale, shake up, be mixed with need testing solution.

[0086] Precisely measure 25 μ L of the test solution prepared in Example 3, and detect and analyze according to the detection conditions of Example 1, see Figure 5 .

[0087] Figure 5 It shows that the analysis method of the present invention can effectively and accurately separate irinotecan hydrochloride and its isomers in irinotecan hydrochloride injection. After the method is optimized, the unknown impurity peak no longer interferes with the determination of isomer impurities. In the stability test , the isomer content did not increase significantly. The optical purity of this product has reached the quality requirements, indicating that this method is suitable for the detection of isomer impurities in irin...

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Abstract

The invention discloses a method for detecting isomers in irinotecan hydrochloride injection. An isocratic elution method is used for detection on a high performance liquid chromatograph, and a chromatographic column is a bonded chiral chromatographic column; a mobile phase is a mixture of methanol, absolute ethyl alcohol, normal hexane and diethylamine; the detection wavelength of an ultravioletdetector is 370nm; the flow velocity of the mobile phase is 1.7 mL / min to 1.9 mL / min; the column temperature is 30-40 DEG C; and the diluent is a mixture of phosphoric acid and absolute ethyl alcohol.The method can eliminate baseline fluctuation and interference of unknown impurities, achieves separation and determination of irinotecan hydrochloride injection isomer impurities, and has the advantages of high accuracy and strong specificity.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and relates to a method for analyzing isomers in irinotecan hydrochloride injection by using high performance liquid chromatography. Background technique [0002] Irinotecan Hydrochloride (Irinotecan Hydrochloride), whose chemical name is L-(+)-N-[4-[[(2,4-diamino-6-pteridyl)methylamino]benzyl trihydrate, is half Synthetic camptothecin derivatives, this product and its metabolite SN-38 are DNA topoisomerase 1 inhibitors, which have a strong killing effect on various cancer cells such as lung cancer and colon cancer. The drug was developed by Japan's Daiichi Seiy-aku and Yakult Honsha, and was first launched in Japan in 1994, and is now available in more than 20 countries. Its structural formula is as shown in formula 1: [0003] [0004] Irinotecan hydrochloride has a chiral center. According to the regulations of the United States Pharmacopoeia (USP), the isomer content of irinotecan ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/34G01N30/60
CPCG01N30/88G01N30/34G01N30/60G01N2030/8872
Inventor 柯锐付强刘青徐兴志
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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