The Development of Analytical Method for the Determination of Azelaic Acid Content in Cosmetic Cream Products

Azelaic acid is one of the substances that has anti-acne and skin lightening effects which is often added to cosmetics. In the acne treatment, the azelaic acid is generally used with a concentration of 20% in cream formulation and 15% in gel. The use at concentrations below 10% is not recommended because it does not work effectively. While the use of above 10% is categorized as a medical treatment. In Indonesia, the Head of the National Agency of Drug and Food Control (BPOM) has issued Regulation No. 18 of 2015 on the Technical Requirements of Cosmetics Ingredients Annex V stating that the azelaic acid is banned in cosmetics. However, until this research began the BPOM has not had a valid method to identify it in cosmetics. Consequently, surveillance of such ingredient in products is hard to do. In this research, the fatty acid standard analysis method of AOAC International was modified and validated to be used in the laboratory. The method of analysis involves heating the cream preparations dissolved with methanol and then added BF₃-methanol catalyst, followed by extraction and analysis using GCMS. The validation of method shows that the calibration curve is linear with correlative value of 0.9997. The method is fairly sensitive with 0.02% detection limit, and fairly precision with relative standard deviation (RSD) of between 0.626-0.961% and fairly accurate which the recovery percentage is 99.85% at range 98.27-100.72%. In sum the results demonstrate that the method can be used as a routine analysis method for laboratory testing.