Purba, Novalina B. R.Rohman, AbdulMartono, Sudibyo2020-10-162020-10-162019-07Purba Novalina B. R., Rohman Abdul, Martono Sudibyo. Validation and application of reversed-phase high-performance liquid chromatography for quantitative analysis of acid orange 7 and Sudan II in blusher products. Journal of Applied Pharmaceutical Science. 2019 Jul; 2019 Jul: 100-1052231-3354http://imsear.searo.who.int/handle/123456789/210411The objective of this study was to develop and to validate reversed-phase high-performance liquid chromatography(RP-HPLC) method for the determination of acid orange 7 (AO7) and Sudan II (SII) in blusher products. Separationof AO7 and SII was performed using C18 column (Thermo Synergy Gold 250 mm × 4.6 mm i.d., 5 µm) with mobilephase consisting of acetonitrile-water as a solvent (1:1 v/v) and delivered in gradient manner. The mobile phase wasdelivered at flow rate of 0.9 ml/minute, using column temperature of 40°C. RP-HPLC was validated by assessingseveral performance characteristics which included selectivity, linearity and range, sensitivity, precision, accuracy, androbustness. The developed RP-HPLC was selective for the separation of AO7 and SII. Over concentration of 10.326–41.304 µg/ml (AO7) and 9.967–39.869 (SII), the method was linear with coefficient of correlation (r) >0.999. Themethod was sensitive as indicated by low limit of detection and limit of quantification. The relative standard deviation(RSD) values during intra-assay and inter-assay were lower than those required by RSD Horwitz. The percentageof recovery was within acceptable ranges as required by Association of Official Analytical Chemists method. Thevalidated RP-HPLC method has been successfully applied for the analysis of AO7 and SII in commercial blusherproducts, and both AO7 and SII were not detected in the tested samples.Acid orange 7Sudan IIRP-HPLCblusher products.Journal ArticleIndiaDepartment of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, IndonesiaThe National Agency of Drug and Food Control, District of Denpasar 80235, Bali, Indonesia.Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, IndonesiaInstitute of Halal Industry and Systems (IHIS), Universitas Gadjah Mada, Yogyakarta 55281, Indonesia.Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia