Method for simultaneously detecting methylparaben, propylparaben and dibutyl hydroxy toluene in gel

A technology of acetic acid and diluent, applied in the field of medicine and chemical industry, can solve problems such as long running time

Active Publication Date: 2015-02-25
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0010] However, this method takes a long time to run and is only...

Method used

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  • Method for simultaneously detecting methylparaben, propylparaben and dibutyl hydroxy toluene in gel
  • Method for simultaneously detecting methylparaben, propylparaben and dibutyl hydroxy toluene in gel
  • Method for simultaneously detecting methylparaben, propylparaben and dibutyl hydroxy toluene in gel

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Embodiment Construction

[0019] A kind of method for measuring Me-PHBA, Pr-PHBA and BHT in the gel simultaneously provided by the invention, described method feature is:

[0020] Instrument: high performance liquid chromatography;

[0021] Chromatographic column: Agilent ZORBAX SB-C18, 4.6mm×250mm, 5μm;

[0022] Mobile phase: 1% aqueous acetic acid and acetonitrile;

[0023] Elute with the following gradient:

[0024] time (min)

1% acetic acid aqueous solution % (v / v)

Acetonitrile%(v / v)

[0025] 0

50

50

5

50

50

8

10

90

15

10

90

17

50

50

25

50

50

[0026] Detector: UV detector, detection wavelength 254nm and 278nm;

[0027] Flow rate: 0.8ml / min~1.2ml / min;

[0028] Column temperature: 25°C-35°C;

[0029] Injection volume: 1μL~100μL;

[0030] Running time: 25min.

[0031] In some embodiments, the flow rate of the methods described herein is 1.0 ml / min.

[0032] In some embod...

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Abstract

The invention provides a method for simultaneously analyzing and detecting methylparaben (Me-PHBA), propylparaben (Pr-PHBA) and dibutyl hydroxy toluene (BHT) in clindamycin phosphate gel. According to the method, Agilent ZORBAX SB-C18 (4.6mm*250mm, 5 mu-m) is adopted as a chromatographic column, an acetonitrile-1% acetic acid aqueous solution is used as a moving phase for gradient elution, double wavelengths (the detecting wavelength for detecting Pr-PHBA and Me-PHBA is 250-260nm, and the wavelength for detecting BHT is 270-286nm) are adopted for analyzing and detecting. The analyzing method is quick, has the advantages of good specificity and high sensitivity, is suitable for detecting contents of Me-PHBA, Pr-PHBA and BHT in a medicine preparation, in particular a gel.

Description

technical field [0001] This field belongs to the field of medicine and chemical industry, in particular to a simultaneous determination of methyl p-hydroxybenzoate (Me-PHBA), propyl p-hydroxybenzoate (Pr-PHBA) and dibutyl hydroxytoluene (BHT) in gel analysis and detection methods. Background technique [0002] Preservatives and antioxidants are very commonly used substances in the field of pharmaceutical preparations, especially in dosage forms such as gels and creams. They generally act as antimicrobials and prevent oxidative deterioration of unstable drugs in specific pharmaceutical formulations. Usually, in order to make pharmaceutical preparations have good stability, preservatives and antioxidants are generally used in combination. [0003] The more commonly used preservatives include Me-PHBA, Pr-PHBA, etc.; the more commonly used antioxidants include BHT, propyl gallate, etc. [0004] Due to the toxicity of preservatives themselves, ICH clearly proposes that a metho...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 黄科沈耀成黄芳芳曹现峰宋学志
Owner SUNSHINE LAKE PHARM CO LTD
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