Development and validation of a method for simultaneous quantification of azelaic acid and the preservative benzoic acid in topical gel by high performance liquid chromatography

Quang Thao Le, Thi Hang Nguyen, Thi Thu Huyen Hua, Thi Thanh Thao Hoang

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Abstract

A reversed-phase HPLC method for simultaneous determination of acid azelaic and acid benzoic in topical gel was introduced. The method was carried out on a C18 column (4.6 mm x 250 mm, 5 µm), using a methanol – amoni acetat buffer pH 4.5 mixture (20 : 80, v/v) as mobile phase. The mobile phase flow rate was maintained at 1.0 mL per minute. Injection volumn was 20 µL. The UV dectector was set at 230 nm. The developed method has been illustrated to statisfy the requirements of specificity, system suitability, linearity, accuracy, precision (repeatability and intermediate precision) according to ICH-(Q2R1) guideline. The validation results indicated that the developed procedure was suitable for simultaneous determination of acid azelaic and acid benzoic in studied gel and may be applied in laboratories.

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References

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