Article Per Year (5 Year)
p-Index From 2020 - 2025
0.817
P-Index
This Author published in this journals
All Journal Eruditio : Indonesia Journal of Food and Drug Safety
Isnaeni, Neni
Unknown Affiliation
Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemistry Medicine & Pharmacology Public Health

Published : 4 Documents Claim Missing Document
Claim Missing Document
Check
Articles

Found 4 Documents
Search

 1 
Studi dan Karakterisasi Bahan Baku Resorsinol sebagai calon Baku Pembanding dan Pengembangan Metode Analisis Penetapan Kadar Resorsinol dalam Bahan Baku Isnaeni, Neni; Dwirini, Nurul
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 2 (2023): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v3i2.121

Abstract

Resorcinol is often misused for antiacne cosmetics. Corresponding to Indonesian FDA regulation, it is only allowed for hair dyes, hair lotion, and shampoo. Reference standard and analytical method of Resorcinol are needed for strengthening capability and capacity of Indonesian FDA for post-market controlling of cosmetics in Indonesia. Therefore, this research developed a reference standard by study and characterization and an analytical method for assay Resorcinol in raw material. Characterization of Resorcinol raw material using infrared spectrophotometry and HPLC-PDA, purity testing with TLC, HPLC, and DSC, homogeneity testing and assay by HPLC-PDA. Development analytical method for assay of Resorcinol was performed using an HPLC - PDA system with Waters Atlantis T3-C18 (5µm, 250 x 4.6 mm) column. The column temperature was set at 25°C. The mobile phase consists of ortho-phosphoric acid 0.085% pH 3 and methanol (50:50 v/v), delivered at a 1.0 mL/min flow rate. Detection was carried out at 274 nm. Resorcinol characterization using infrared spectrophotometry showed the presence of aromatic C-H bond functional groups (3100 – 3000 cm-1), C-H bonds (1374 and 773 cm-1), C-OH bonds (1311-1298, 1166; 1151 and 460 cm-1), C-C bonds (1608 and 1490 cm-1), aromatic rings (543 cm-1), and meta di-substituted ring groups (842 and 739 cm-1). Purity testing by TLC and HPLC were obtained that no spots or other peaks detected, indicating that the material has high purity. Purity by DSC of 99.05% and melting point of 109.41°C. The sample was homogenous with a content of 99.28% on a dried basis. Furthermore, the developed method has a linear range of 0.1 – 0.3 mg/mL at a coefficient correlation of 0.9999 and Vx0 of 0.5%. The limit of detection is 0.11 µg/mL, while the limit of quantification is 0.34 µg/mL and accuracy (% bias) of 0.10%. All validation parameters have met the requirement. These results meet the criteria for the candidate of a reference standard and the developed method is accurate, reliable, and valid so it can be applied to determine Resorcinol in raw material.
Validasi Metode Analisis Penetapan Kadar Bahan Baku Lapatinib Ditosylate secara KCKT-DAD Nopi, Nely Suryani; Isnaeni, Neni
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 1 (2023): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i1.178

Abstract

The validation analytical method of the Lapatinib ditosylate assay is crucial to increase testing capability and capacity in strengthening the supervision of post-marketing drugs in Indonesia. A fast, precise, accurate, valid, and efficient test method is needed to carry out the test. A previous study on determining Lapatinib ditosylate assay generally used a C18 column, yet for efficiency, it is also necessary to develop a test method that can use existing resources in the laboratory, where the research used a C8 column. In this study, an analytical method to determine the assay of Lapatinib ditosylate developed using a High-Performance-Liquid Chromatography-Diode Array Detector (HPLC-DAD) system equipped with an autosampler and XBridge ® C8 column (Waters); 250 x 4.6 mm i.d. 5 μm. The mobile phase consisted of pentane-1-sulfonic acid sodium salt 10 mM - acetonitrile (65:35) eluted isocratically at a 0.6 mL/min flow rate. Detection was carried out at a wavelength of 222 nm. The analytical method was validated with test parameters of selectivity, system suitability, accuracy, precision, linearity, detection limit and quantification limit. Results from the validation study demonstrated a retention time of 4.63 minutes, good linear in the concentration range of 0.06 – 0.18 mg/mL with a correlation coefficient and Vx0 of 1.00000 and 0.1%. Test accuracy (% bias) obtained a value of 0.77% with precision (system, method and intermediate) less than 2.0%. The detection and quantification limits were 0.67 µg/mL and 2.02 µg/mL. Based on the research results, it can be concluded that the method developed provides fast, accurate and valid performance. Validation of the Analytical Method for Determining Lapatinib Ditosylate Raw Material Contents using HPLC-DAD.
Development and Validation of a Method for Detecting and Quantifying Mitragynine in Kratom Samples Using HPLC-PDA Isnaeni, Neni; Saefumillah, Asep; Cahyana , Antonius Herry
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.v4i2.209

Abstract

Kratom (Mitragyna speciosa Korth) has been identified as a New Psychoactive Substance (NPS) by the United Nations Office on Drugs and Crime (UNODC) and included in the list of prohibited ingredients in food supplements and traditional medicine by Indonesian FDA. Therefore, a rapid, easy, and reliable analytical method is necessary to detect and quantify this plant and its products. This study developed a method for the detection and quantification of kratom products based on a unique compound, mitragynine, as a biomarker. A previous survey of determining mitragynine in Kratom using GC-MS, LC-MS/MS, UPLC, and HPLC-PDA. Previously, the HPLC-PDA method used a C8 column. Yet, for efficiency, it is also necessary to develop a test method using a C18 column. Analysis was performed using an HPLC - PDA system with Waters Atlantis T3-C18 (250 x 4.6 mm, 5 µm) column. The mobile phase comprises acetonitrile and formic acid 0.05%, pH 5.0 (75:25 v/v), delivered at a 1.0 mL/min flow rate. Detection was carried out at a wavelength of 225 nm. The analytical method was validated with test parameters of selectivity, system suitability, accuracy, precision, linearity, detection limit, and quantification limit. The validation study demonstrated an excellent linear concentration range of 1.96 - 6.01 µg/mL with a correlation coefficient of 0.9996; the detection limit is 0.14 µg/mL, while the limit of quantification is 0.45 µg/mL—accuracy method of 98.88 - 101.44% and a bias of 0.27%. The percent relative standard deviation for six independent assay determinations was 0.67%, and the intermediate precision was 1.56% on two days. The mitragynine amounts in these materials ranged from 6.01 to 6.31 mg/g of dried leaf material. Based on the research results, it can be concluded that the method developed provides quick, simple, reliable, accurate, and valid, and has an advantage over existing methods in terms of simplicity of sample preparation, short analysis time, and cost-effectiveness compared to GCMS and LCMS/MS and can be applied for future analysis in Kratom samples.
Studi Stabilitas Baku Pembanding Glukosamin Hidroklorida: Penerapan ISO 17034:2016 dalam Memastikan Kualitas dan Validitas Pengujian Farmasi Isnaeni, Neni
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 2 (2025): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i2.205

Abstract

Reference standards are essential in drug and food control to ensure the quality and validity of test results. According to ISO 17034:2016, the Center for National Quality Control Laboratory of Drugs and Food (PPPOMN), as a producer of reference materials, must evaluate and monitor the stability of the standards it produces. Stability testing is critical to maintain product quality during storage and use. However, PPPOMN-developed reference standards had not undergone stability testing to determine shelf life. This study therefore conducted a stability assessment of the Glucosamine hydrochloride reference standard to ensure stability during transportation, distribution, and storage. Long-term stability tests were conducted at 4–8°C at 0 months (control), 72 months, and 144 months. Short-term stability tests were performed at 25°C and 60°C for 72, 120, 168, and 240 hours, with 0 hours as the control. Stability analysis was performed using validated High-Performance Liquid Chromatography (HPLC), and analyte stability was assessed using a t-test. Results indicated that the Glucosamine hydrochloride secondary reference standard remained stable under recommended storage conditions for 144 months and at distribution temperatures up to 60°C for 240 hours (t-count = 0.976). These findings demonstrate that the reference standard maintains its quality under specified conditions, ensuring the reliability and validity of pharmaceutical testing. The study concludes that the glucosamine hydrochloride reference standard has guaranteed quality and can be used as long as it is stored under the recommended conditions and shelf life. Information regarding storage conditions and shelf life can be included on the reference standard label.
Co-Authors Asep Saefumillah Cahyana , Antonius Herry Dwirini, Nurul Nopi, Nely Suryani