XÂY DỰNG PHƯƠNG PHÁP SẮC KÝ KHÍ ĐỂ ĐỊNH LƯỢNG ĐỒNG THỜI MENTHOL, CAMPHOR, METHYL SALICYLATE TRONG KEM COBRATOFOR

Abstract

ABSTRACT

Objective: Develop and validate a method to simultaneously quantify menthol, camphor, and methyl salicylate in Cobratofor cream using gas chromatography with FID detector. Methods: select chromatographic conditions and validate analytical methods according to ICH general guidelines. Results: Chromatography conditions with HP5 column (0.32 mm x 30 m x 0.25 µm) have been selected; Nitrogen carrier gas at 1.1 ml/min; injection chamber temperature 250^oC with flow ratio 10:1; flame ionization detector (FID) 270^oC; Column oven temperature maintained at 100ºC for 3 minutes, increased 5ºC/min to 150ºC, increased 25ºC/min to 250ºC and maintained for 3 minutes; volume injection is 1 µl. Validation results show that the method has high specificity; Good linearity with correlation coefficient from 0.9996-0.9999; High accuracy with recovery of camphor from 98.79%-101.8%, menthol from 99.15%-101.97%, methyl salicylate from 98.02%-101.81%; Good repeatability with relative standard deviation (RSD%) of camphor, menthol and methyl salicylate being 0.73%, 0.68% and 0.72%, respectively. Limits of detection from 0.48 µg/ml-3.84 µg/ml; Limits of quantitation from 1.58 µg/ml-12.67 µg/ml. Conclusion: The method for simultaneous quantification of menthol, camphor, and methyl salicylate using gas chromatography has been validated, the analysis method meets the requirements of ICH.