Article Per Year (5 Year)
p-Index From 2019 - 2024
0.444
P-Index
This Author published in this journals
All Journal JURNAL ILMU KEFARMASIAN INDONESIA Eruditio : Indonesia Journal of Food and Drug Safety
Sitoresmi Triwibowo
Unknown Affiliation
Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemistry Medicine & Pharmacology Public Health

Published : 2 Documents Claim Missing Document
Claim Missing Document
Check
Articles

Found 2 Documents
Search

 1 
Batas Deteksi dan Sensitivitas Metode Deteksi Staphylococcus aureus dalam Sediaan Obat Nur Aini; Sitoresmi Triwibowo
JURNAL ILMU KEFARMASIAN INDONESIA Vol 21 No 1 (2023): JIFI
Publisher : Fakultas Farmasi Universitas Pancasila

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.35814/jifi.v21i1.1157

Abstract

Stapylococcus aureus is a pathogen that should be absent in pharmaceutical products. Contamination of certain microorganisms can potentially reduce or inactivate therapeutic activity, affect the stability, efficacy and cause infection of the patient. Microbial detection methods must be valid and sensitive to detect the contamination of microorganisms at low concentrations. The standard method of S. aureus refers to the Indonesian Pharmacopoeia (FI). LOD and sensitivity of the method in general is not stated in FI. This study aims to determine LOD and sensitivity of S. aureus method on pharmaceutical products with route of administration in cutan, oromucosal, gingival, auricular, vaginal and oral based on Indonesian Pharmacopoeia. Experiments used nine pharmaceutical products representing six dosage forms contaminated with S. aureus ATCC 6538 with three level concentrations of ±1, ±3, and ±5 CFU per g atau mL sample. LOD and sensitivity were determined and analyzed descriptively. This study shows that the detection limit is 1-3 colonies per g or mL sample and a sensitivity of 100%. Results of this study can be used as reference for LOD value in the validation or verification process of the S. aureus detection method in the laboratory to ensure validity of the methods used.
Penetapan Limit of Detection (LOD) dan Sensitivitas Metode Deteksi Pseudomonas aeruginosa dalam Berbagai Matriks Sediaan Obat Nur Aini; Maria Purba; Sitoresmi Triwibowo; Nenden Sholihatul; Ratna Wulandari
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (618.059 KB) | DOI: 10.54384/eruditio.v1i2.85

Abstract

Contamination of certain microorganisms in pharmaceutical products can potentially reduce or even inactivate therapeutic activity and harm patient health. Pharmacopoeia monograph determine the microbiological quality in medicinal products. One of them is P. aeruginosa parameters which should not be present in pharmaceutical preparations. Pharmacopoeia states that microbial detection methods must be able to detect microorganisms, including P.aeruginosa not more than 100 colonies, but the actual detection limit has never been set quantitatively and many variables can affect the microorganism recovery. This study aims to determine the range of Limit of Detection (LOD) values and the sensitivity of the P. aeruginosa method on pharmaceutical products. Detection method of P. aeruginosa refers to the specific microbial test of the Indonesian Pharmacopoeia VI (2020) is culture media methods. Experiments used eight pharmaceutical products representing five dosage forms contaminated with P. aeruginosa ATCC 9027 with three levels of concentration. The results determined LOD range and sensitivity of P. aeruginosa detection method in pharmaceutical products, and analyzed descriptively. This study shows that pharmacopeia method of P. aeruginosa testing can detect P. aeruginosa in various drug preparation matrices with a detection limit of 1-10 colonies and a sensitivity of 100%. Results of this study can be used as reference for LOD value in the verification of the P. aeruginosa detection in medicinal product.
Co-Authors Maria Purba Nenden Sholihatul NUR AINI Ratna Wulandari Salsabila, Unik Hanifah