ANALYSIS AND VALIDATION OF DETECTION METHOD FOR ETHYLENE AND DIETHYLENE GLYCOL CONTAMINANTS IN SYRUP USING GCMS (GAS CHROMATOGRAPHY-MASS SPECTROMETER)
Ethylene glycol (EG) and diethylene glycol (DEG) are hazardous compounds if ingested by the human body. Testing conducted by the Indonesian National Agency of Drug and Food Control (BPM) identified contamination of EG and DEG in glycerin and propylene glycol, which are utilized as solubility enhanc...
Saved in:
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | Indonesian |
| Published: |
Universitas Muhammadiyah Magelang
2025-06-01
|
| Series: | Jurnal Farmasi Sains dan Praktis |
| Subjects: | |
| Online Access: | https://journal.unimma.ac.id/index.php/pharmacy/article/view/11180 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850106188111282176 |
|---|---|
| author | Supandi Supandi Mabrurotul Mustafidah Siti Yaenap Walid Rumblat |
| author_facet | Supandi Supandi Mabrurotul Mustafidah Siti Yaenap Walid Rumblat |
| author_sort | Supandi Supandi |
| collection | DOAJ |
| description |
Ethylene glycol (EG) and diethylene glycol (DEG) are hazardous compounds if ingested by the human body. Testing conducted by the Indonesian National Agency of Drug and Food Control (BPM) identified contamination of EG and DEG in glycerin and propylene glycol, which are utilized as solubility enhancers in syrup-based pharmaceuticals. This study aims to analyze EG and DEG contamination in children’s syrup drug samples using a Gas Chromatography-Mass Spectrometry (GC-MS) instrument. This study presents an analytical method for detecting EG and DEG contamination. Based on BPOM regulations governing the control a determination of EG and DEG. Several syrup drug samples, which are listed in the BPOM drug withdrawal list under Number HM.01.1.2.11.22.240, were each weighed at 5 grams, transferred into a 50 mL volumetric flask, 30 mL of methanol was added, and the mixture was sonicated for 5 minutes. Subsequently, solvent was added up to the calibration mark. Five out of eight samples were found to contain EG and DEG at concentrations of less than 0.1%. Validation of the GCMS method for EG and DEG compounds yielded accuracy values with recovery rates between 98% and 101%. The acquisition test results produced a relative standard deviation (RSD) value of 0.87. The linearity test showed a correlation coefficient (r) of 0.955. The limit of detection (LOD) for EG was 0.26 ng/mg, and for DEG it was 0.51 ng/mg. The limit of quantification (LOQ) for EG was 0.86 ng/mg, and for DEG it was 1.69 ng/mg. This validation indicates that the analytical method exhibits high accuracy and sensitivity.
|
| format | Article |
| id | doaj-art-eb015f31aec5476d8b7532f48e92e658 |
| institution | OA Journals |
| issn | 2549-9068 2579-4558 |
| language | Indonesian |
| publishDate | 2025-06-01 |
| publisher | Universitas Muhammadiyah Magelang |
| record_format | Article |
| series | Jurnal Farmasi Sains dan Praktis |
| spelling | doaj-art-eb015f31aec5476d8b7532f48e92e6582025-08-20T02:38:52ZindUniversitas Muhammadiyah MagelangJurnal Farmasi Sains dan Praktis2549-90682579-45582025-06-0111210.31603/pharmacy.v11i2.11180ANALYSIS AND VALIDATION OF DETECTION METHOD FOR ETHYLENE AND DIETHYLENE GLYCOL CONTAMINANTS IN SYRUP USING GCMS (GAS CHROMATOGRAPHY-MASS SPECTROMETER)Supandi Supandi0Mabrurotul Mustafidah1Siti Yaenap2Walid Rumblat3Department of Pharmaceutical Chemistry, Faculty of Health Science, Universitas Islam Negeri Syarif Hidayatullah Jakarta, Tangerang Selatan 15411, IndonesiaDepartment of Pharmaceutical Chemistry, Faculty of Health Science, Universitas Islam Negeri Syarif Hidayatullah Jakarta, Tangerang Selatan 15411, IndonesiaDepartment of Pharmaceutical Chemistry, Faculty of Health Science, Universitas Islam Negeri Syarif Hidayatullah Jakarta, Tangerang Selatan 15411, IndonesiaDepartment of Pharmaceutical Chemistry, Faculty of Health Science, Universitas Islam Negeri Syarif Hidayatullah Jakarta, Tangerang Selatan 15411, Indonesia Ethylene glycol (EG) and diethylene glycol (DEG) are hazardous compounds if ingested by the human body. Testing conducted by the Indonesian National Agency of Drug and Food Control (BPM) identified contamination of EG and DEG in glycerin and propylene glycol, which are utilized as solubility enhancers in syrup-based pharmaceuticals. This study aims to analyze EG and DEG contamination in children’s syrup drug samples using a Gas Chromatography-Mass Spectrometry (GC-MS) instrument. This study presents an analytical method for detecting EG and DEG contamination. Based on BPOM regulations governing the control a determination of EG and DEG. Several syrup drug samples, which are listed in the BPOM drug withdrawal list under Number HM.01.1.2.11.22.240, were each weighed at 5 grams, transferred into a 50 mL volumetric flask, 30 mL of methanol was added, and the mixture was sonicated for 5 minutes. Subsequently, solvent was added up to the calibration mark. Five out of eight samples were found to contain EG and DEG at concentrations of less than 0.1%. Validation of the GCMS method for EG and DEG compounds yielded accuracy values with recovery rates between 98% and 101%. The acquisition test results produced a relative standard deviation (RSD) value of 0.87. The linearity test showed a correlation coefficient (r) of 0.955. The limit of detection (LOD) for EG was 0.26 ng/mg, and for DEG it was 0.51 ng/mg. The limit of quantification (LOQ) for EG was 0.86 ng/mg, and for DEG it was 1.69 ng/mg. This validation indicates that the analytical method exhibits high accuracy and sensitivity. https://journal.unimma.ac.id/index.php/pharmacy/article/view/11180Diethylene GlycolEthylene GlycolGC-MSDrugs |
| spellingShingle | Supandi Supandi Mabrurotul Mustafidah Siti Yaenap Walid Rumblat ANALYSIS AND VALIDATION OF DETECTION METHOD FOR ETHYLENE AND DIETHYLENE GLYCOL CONTAMINANTS IN SYRUP USING GCMS (GAS CHROMATOGRAPHY-MASS SPECTROMETER) Jurnal Farmasi Sains dan Praktis Diethylene Glycol Ethylene Glycol GC-MS Drugs |
| title | ANALYSIS AND VALIDATION OF DETECTION METHOD FOR ETHYLENE AND DIETHYLENE GLYCOL CONTAMINANTS IN SYRUP USING GCMS (GAS CHROMATOGRAPHY-MASS SPECTROMETER) |
| title_full | ANALYSIS AND VALIDATION OF DETECTION METHOD FOR ETHYLENE AND DIETHYLENE GLYCOL CONTAMINANTS IN SYRUP USING GCMS (GAS CHROMATOGRAPHY-MASS SPECTROMETER) |
| title_fullStr | ANALYSIS AND VALIDATION OF DETECTION METHOD FOR ETHYLENE AND DIETHYLENE GLYCOL CONTAMINANTS IN SYRUP USING GCMS (GAS CHROMATOGRAPHY-MASS SPECTROMETER) |
| title_full_unstemmed | ANALYSIS AND VALIDATION OF DETECTION METHOD FOR ETHYLENE AND DIETHYLENE GLYCOL CONTAMINANTS IN SYRUP USING GCMS (GAS CHROMATOGRAPHY-MASS SPECTROMETER) |
| title_short | ANALYSIS AND VALIDATION OF DETECTION METHOD FOR ETHYLENE AND DIETHYLENE GLYCOL CONTAMINANTS IN SYRUP USING GCMS (GAS CHROMATOGRAPHY-MASS SPECTROMETER) |
| title_sort | analysis and validation of detection method for ethylene and diethylene glycol contaminants in syrup using gcms gas chromatography mass spectrometer |
| topic | Diethylene Glycol Ethylene Glycol GC-MS Drugs |
| url | https://journal.unimma.ac.id/index.php/pharmacy/article/view/11180 |
| work_keys_str_mv | AT supandisupandi analysisandvalidationofdetectionmethodforethyleneanddiethyleneglycolcontaminantsinsyrupusinggcmsgaschromatographymassspectrometer AT mabrurotulmustafidah analysisandvalidationofdetectionmethodforethyleneanddiethyleneglycolcontaminantsinsyrupusinggcmsgaschromatographymassspectrometer AT sitiyaenap analysisandvalidationofdetectionmethodforethyleneanddiethyleneglycolcontaminantsinsyrupusinggcmsgaschromatographymassspectrometer AT walidrumblat analysisandvalidationofdetectionmethodforethyleneanddiethyleneglycolcontaminantsinsyrupusinggcmsgaschromatographymassspectrometer |