Method for determining content of mythyl p-hydroxybenzoate and sodium benzoate in solution

Abstract

The invention relates to a method for determining content of mythyl p-hydroxybenzoate and sodium benzoate in a solution. The method is characterized in that a high performance liquid chromatography is adopted, and chromatographic conditions are adaptive to a system: octadecyl bonded silane is used as a filling agent and 1% acetonitrile-acetic acid is used as a mobile phase, wherein a volume ratio of a water phase to an organic phase is 72-70:28-30; a detection wavelength is 230 nm; a flow velocity is 0.6-1.0 ml per minute; a column temperature is 30+ / -5 DEG C; a number of theoretical plates is not smaller than 3,000 in terms of sodium benzoate; and a degree of separation is larger than 2.0. The method comprises the steps of precisely measuring a proper amount of a drug preparation solution; adding a mobile phase to dilute the solution into a test liquid with required concentration; shaking uniformly; injecting 10 [mu]L of the sample in a liquid chromatograph; recording a chromatogram; measuring methyl 4-hydroxybenzoate and sodium benzoate as reference substances; determining by using the same method; and calculating according to peak area by using an external standard method. With the method, quantitative analysis of methyl 4-hydroxybenzoate and sodium benzoate can be completed under the same chromatographic conditions; the determination method is simple and practicable; and the determined indexes are accurate.

Description

Technical field: [0001] The invention relates to the field of chemical testing and the technical field of drug analysis, in particular to a method for determining the content of methyl p-hydroxybenzoate and sodium benzoate in a solution. Background technique: [0002] An existing pharmaceutical preparation contains two preservative ingredients: methyl p-hydroxybenzoate and sodium benzoate. At present, there is no analytical method for simultaneous detection of both under the same chromatographic conditions. [0003] Methyl p-hydroxybenzoate, also known as methyl paraben, has a strong antibacterial effect, and it has an ideal effect on preventing fermentation and mildew of the preparation when used in combination with sodium benzoate. [0004] At present, the detection methods of these two preservatives can only be tested for the content of a single methyl p-hydroxybenzoate and sodium benzoate. If the content determination of the two components is carried out separately, the ...

AI Technical Summary

Problems solved by technology

[0004] At present, the detection methods of these two preservatives can only be tested for the content of a single methyl p-hydroxybenzoate and sodium benzoate. If the content determination of the two components is carried out separately, the test method is cumbersome, and the workload of the test personnel and the requirements of the analytical instruments The allocation and use need to be increased accordingly, resulting in passive and wasteful work arrangements

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