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Method for separating and determining dapoxetine hydrochloride and potential genetic toxicity impurities thereof

A technique for dapoxetine hydrochloride and genotoxicity, applied in the field of analytical chemistry, to achieve the effect of strong specificity, simple operation method and high accuracy

Active Publication Date: 2016-05-04
CHONGQING HUABANGSHENGKAI PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is currently no published method reporting the method for the separation and determination of dapoxetine hydrochloride and its potential genotoxic impurities

Method used

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  • Method for separating and determining dapoxetine hydrochloride and potential genetic toxicity impurities thereof
  • Method for separating and determining dapoxetine hydrochloride and potential genetic toxicity impurities thereof
  • Method for separating and determining dapoxetine hydrochloride and potential genetic toxicity impurities thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] (1) Instruments and conditions

[0070] High performance liquid chromatography: SHIMADZULC-2010AHT;

[0071] Chromatographic column: VP-ODS (250×4.6mm, 5μm);

[0072] Wavelength: 210nm;

[0073] Column temperature: 30°C; flow rate: 1.0ml / min;

[0074] Injection volume: 20μl;

[0075] Mobile Phase I: Gradient Elution

[0076] time (min)

Acetonitrile (%)

water(%)

0

45

55

4

45

55

30

90

10

35

45

55

45

45

55

[0077] Diluent: the volume ratio of acetonitrile and water is 45:55

[0078] (2) Experimental steps

[0079] UI-1 Positioning Solution: Accurately weigh 20.15mg of the sample, put it in a 50ml measuring bottle, add diluent to dissolve and dilute to the mark, and mix well.

[0080] 3-Chloropropiophenone positioning solution: Accurately weigh 20.32mg of the sample, put it in a 50ml measuring bottle, add diluent to dissolve and dilute to the mark, and mix well.

[0...

Embodiment 2

[0090] 1) Instruments and conditions

[0091] High performance liquid chromatography: SHIMADZULC-2010AHT;

[0092] Chromatographic column: WatersXTerraRP18 (3.0×150mm, 3.5μm);

[0093] Detection wavelength: 225nm Flow rate: 0.6ml / min

[0094] Column temperature: 35°C Injection volume: 10μl

[0095] Mobile phase II:

[0096] Mobile phase A: 10mmol / L ammonium bicarbonate and 6mmol / L diethylamine aqueous solution

[0097] Mobile Phase B: Acetonitrile

[0098] time (min)

Flow A(%)

Mobile phase B(%)

0

55

45

20

5

95

22

55

45

30

55

45

[0099] Diluent: Acetonitrile

[0100] (2) Experimental steps

[0101] UI-1 Positioning Solution: Accurately weigh 20.15mg of the sample, put it in a 50ml measuring bottle, add diluent to dissolve and dilute to the mark, and mix well.

[0102] 3-Chloropropiophenone positioning solution: Accurately weigh 20.32mg of the sample, put it in a 50ml measuring bottle, add...

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Abstract

The invention relates to the field of analysis chemistry, in particular to a method for separating and determining dapoxetine hydrochloride and potential genetic toxicity impurities thereof. The method adopts octadecyl silane bonded silica gel as a stationary phase for performing solid and liquid separation, a moving phase is a moving phase I or a moving phase II, the moving phase I is a water solution of acetonitrile, and the moving phase II is a water solution of acetonitrile, ammonium bicarbonate and diethylamine. The potential genetic toxicity impurities comprise 3-chloropropiophenone, UI-1, SM1e and Z1b. The method can realize effective separating of dapoxetine hydrochloride and potential genetic toxicity impurities thereof, can accurately detect whether the potential genetic toxicity impurities exceed the limit, and is high in specificity and high in accuracy. The operating method is simple, has the advantages of simplicity and rapidness, and has very important significance in quality control and safety guarantee of the dapoxetine hydrochloride.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, in particular to a method for separating and measuring dapoxetine hydrochloride and its potential genotoxic impurities. Background technique [0002] Dapoxetine Hydrochloride, chemical name S-(+)-N,N-dimethyl-1-phenyl-3-(1-naphthyloxy)propylamine hydrochloride, English name (S-( +)-N,N-dimethyl-3-(naphthalene-1-yloxy)-1-phenylpropan-1-amineHydrochloride), is the hydrochloride of dapoxetine, and the original manufacturer of dapoxetine is Eli Lili, USA company, whose original patent EP0288188 describes the preparation of dapoxetine. Dapoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI), which is a short-acting SSRI. Compared with the traditional long-acting SSRI, it has the characteristics of fast drug effect, short half-life, and low side effects. For the treatment of depression and related affective disorders. Dapoxetine hydrochloride can selectively inhibit the reabso...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 曾正英杨治国夏爽
Owner CHONGQING HUABANGSHENGKAI PHARM
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