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Analisis Zink Pirition dalam Sampo Anti Ketombe secara Kromatografi Cair Kinerja Tinggi untuk Mendukung Pengawasan Pre-Market dan Post-Market Zahara, Zahara; Kurniawati, Farida; Lusianti, Erita
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 2 (2024): June Edition
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i2.175

Abstract

ZnPtO is widely used as an active substance in anti-dandruff shampoo. Instead of describing its benefits, many articles have reported that ZnPtO can harm the environment and human health. Through the Food and Drugs Administration, Indonesia has been regulated to have a maximum limit of 2.0% for rinse-off hair products. The research aims to develop an accurate and reliable method to determine product ZnPtO level. ZnPtO was analyzed using High-Performance Liquid Chromatography (HPLC) with Photo Diode Array (PDA) at a wavelength of 257.9 nm. This research used a C18 column with dimensions of 250 x 4.6 nm and five μm in particle size. The mobile phase consisted of acetonitrile and a mixture of potassium dihydrogen phosphate solution and disodium EDTA at pH 4.0 (30:70). Column temperature was maintained at 40oC at a 1.0 ml/min flow rate.  The results showed that ZnPtO was detected at a retention time of 7 minutes. The method's correlation coefficient and residual deviation were 0.999% and 0.65%, respectively. Method precision at 20, 100, and 160 μg/ml was 0.6694, 0.4511, and 0.4728%, respectively. Method accuracy at those levels was 98.3 to 100.9%. All validation parameters have fulfilled the qualification. ZnPtO levels contained in anti-dandruff shampoos were 0.0081%, 0.0040%, and 0.016%, respectively. The developed method has proven selective, accurate, and reliable. It can control the quality and safety of anti-dandruff shampoo due to pre-market and post-market surveillance.
Harmonisasi Metode Analisis Pengujian Cemaran 1,4-Dioksan dalam Kosmetik sebagai Upaya Memperkuat Pengawasan Pre-Market Melalui Jejaring Laboratorium Kosmetik di Indonesia Arpan, Susan Gracia; Sri Purwaningsih; Hasti Kusuma; Lusianti, Erita; Yustina, Yustina
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 2 (2024): June Edition
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i2.187

Abstract

Laboratories play a strategic role in protecting public health by ensuring the quality and safety of drugs, food, and cosmetics. The Centre of National Quality Laboratory of Drugs and Food (CNQLDF), as the central laboratory of the Indonesian Food and Drug Authority (Indonesian FDA), continuously develops reliable, selective, sensitive, and accurate analytical methods (AM) for cosmetic testing in line with advancements in cosmetic formulation technology. However, both the Indonesian FDA and external cosmetic laboratories need more human resources and infrastructure, hindering the development of analytical method and the testing of cosmetic products. Strengthening these laboratories through stakeholder networks is essential. Indonesia actively participates in the ASEAN Cosmetic Testing Laboratories Committee (ACTLC) and the Indonesian Cosmetic Laboratory Network (ICLN). One of the main tasks of CNQLDF is to develop a new ASEAN Cosmetic Method (ACM) for 1,4-Dioxane contaminants in cosmetics. Currently, CNQLDF, along with the Indonesia National Standard Body (INSB), Ministries and External Laboratories, in which together became members of ICLN, harmonized the analytical method of 1,4-Dioxane at the national level, leading to the issuance of the Indonesian National Standard (INS). Both the INS and ACM have main purpose to standardize analytical methods across laboratories, ensure the safety and quality of cosmetic products and enhance national product competitiveness. This study examines method to strengthen pre-market cosmetic surveillance through harmonizing the analytical method of 1,4-Dioxane at the national and ASEAN regional levels, using a qualitative approach based on the Indonesian FDA's internal data and stakeholder information on 1,4-Dioxane testing capabilities.