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METHOD FOR DETECTING similar SUBSTANCE derived from TRIFLURIDINE

A technology for trifluridine and substances, which is applied in the field of determination of similar substances in preparations, can solve problems such as unrecorded conditions and no published detection methods, and achieves the effect of ensuring quality

Pending Publication Date: 2019-07-12
TAIHO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] In addition, although high performance liquid chromatography is used to confirm the purity of trifluridine, the conditions are not described (Patent Document 7)
[0017] However, these reports do not disclose a method for detecting trifluridine analogues using high performance liquid chromatography in two steps using gradient conditions.

Method used

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  • METHOD FOR DETECTING similar SUBSTANCE derived from TRIFLURIDINE
  • METHOD FOR DETECTING similar SUBSTANCE derived from TRIFLURIDINE
  • METHOD FOR DETECTING similar SUBSTANCE derived from TRIFLURIDINE

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-1

[0189] Column: Hydrosphere C18, manufactured by YMC Corporation (3 μm)

[0190] Flow rate: 1.0mL / min

[0191] Mobile phase A: 0.05mol / L sodium dihydrogen phosphate aqueous solution

[0192] Mobile Phase B: Acetonitrile

[0193] Gradient: Change the mobile phase A and mobile phase B in the following way to control the concentration gradient. 0~18 minutes: A 95%, B5%; 18~55 minutes: A 95→60%, B 5%→40%; 55~55.1 minutes: A 60%→95%, B 40%→5%; 55.1 Minutes later: A 95%, B 5%.

[0194]The measurement results are shown in figure 1 . From this, it was confirmed that the retention time of trifluridine was 17.2 minutes. In this measurement method, it was confirmed that trifluridine did not overlap with dips or false peaks in the baseline.

Embodiment 1-2

[0196] Gradient: Change the mobile phase A and mobile phase B in the following way to control the concentration gradient. 0~18 minutes: A 95%, B5%; 18~48 minutes: A 95→60%, B 5%→40%; 48~48.1 minutes: A 60%→95%, B 40%→5%; 48.1 Minutes later: A 95%, B 5%.

[0197] Chromatographic column, flow rate, mobile phase A and mobile phase B are the same conditions as in Example 1.

[0198] By this measurement, it was confirmed that trifluridine did not overlap with false peaks.

Embodiment 1-3

[0200] Gradient: Change the mobile phase A and mobile phase B in the following way to control the concentration gradient. 0-20 minutes: A 95%, B5%; 20-50 minutes: A 95→60%, B 5%→40%; 50-50.1 minutes: A 60%→95%, B 40%→5%; 50.1 Minutes later: A 95%, B 5%. Chromatographic column, flow rate, mobile phase A and mobile phase B are the same conditions as in Example 1.

[0201] The measurement results are shown in figure 2 . From this, it was confirmed that the retention time of trifluridine was 17.1 minutes. In this measurement method, it was confirmed that trifluridine did not overlap with dips or false peaks in the baseline.

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PUM

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Abstract

The present invention relates to a method for detecting a similar substance derived from trefluuridine. The present invention provides a novel method that is capable of detecting a trifluridine-related substance from a sample containing trifluridine or a salt thereof by high-performance liquid chromatography comprising two steps that are performed under gradient conditions. The solution of the invention is the method for detecting the similar substance derived from the trefluuridine, and the method comprises the step of subjecting a sample containing trifluridine or a salt thereof to high-performance liquid chromatography using a mobile phase composed of an organic phase and an aqueous phase, wherein the step of high-performance liquid chromatography comprises steps 1 and 2 that satisfy the following requirements: the step 1: the percentage of the organic phase in the entire mobile phase is 1 to 14% by volume; and the step 2: after step 1, a gradient is set to increase the percentage of the organic phase relative to the entire mobile phase.

Description

technical field [0001] The present invention relates to a method for determining similar substances in preparations containing trifluridine by using high performance liquid chromatography. Background technique [0002] In general, similar substances of pharmaceuticals are measured by liquid chromatography, and a normal-phase column system or a reverse-phase column system using a mixture of water and an organic solvent as a mobile phase is often used. Hitherto, trifluridine has been used as an eye drop for treating infection under the name of Viropic (registered trademark), and Lonsurf ("Lonsurf" in Japanese) (registered trademark), which is a product of the applicant, contains trifluridine Preparations of uridine and tipiracil. Such pharmaceuticals containing trifluridine and tipiracil have been marketed as antineoplastic agents, and there have been many reports on such preparations (Patent Documents 1, 2, 3, and 4). [0003] Furthermore, 5-trifluoromethyluracil and 5-carb...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 武田大典小岛章代
Owner TAIHO PHARMA CO LTD
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