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  • 09월 20일 16시 이후 : 초록수정 불가능, 일정확인 및 검색만 가능

제126회 대한화학회 학술발표회 및 총회 Method Validation of N-nitrosodimethylamine in Diltiazem by UPLC-ESI-SRM/MS

2020년 9월 3일 14시 47분 26초
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화 10시 : 20분
Analytical Chemistry - Oral Presentation of Young Analytical Chemists II
저자 및
Keewon Yang, Jae-ung Lee1, Han Bin Oh1,*
Chemistry, Sogang University, Korea
1Department of Chemistry, Sogang University, Korea
In 2018, N-nitrosodimethylamine (NDMA) was first found in Valsartan, which is a drug used for treating hypertension. Since then, NDMA has been discovered in other drugs like Ranitidine and Metaformine. International Agency for Research on Cancer (IARC) classified NDMA as ‘2A’ type chemical, which is a chemical that may act as a carcinogen over ingestion. Different approaches, like GC-MS/MS, thermal desorption GC-MS and LC-MS/MS, were used to identify and quantify NDMA in different drugs and products. In this study, a method validation on NDMA in Diltiazem using the UPLC-ESI-SRM/MS was carried out to see if the method satisfies the guideline suggested by the KP/ICH and Ministry of Food and Drug Safety. Different criteria, like system suitability, specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ) and robustness, were verified. Specificity of NDMA was tested for standard solutions prepared in methanol and two different matrices, capsule and tablets, which turned out to be no difference between the matrices. LOD and LOQ for NDMA in standard solution were 0.1 ng/mL and 2 ng/mL, respectively. The correlation coefficient (R2) of the linear regression line obtained in the concentration range of 2–100 ng/mL was 0.9992. The accuracy and precision of the method were also satisfied. In the future study, inter-laboratory precision and robustness of the method will be verified for drug substances and drug products. This research was supported by Ministry of Food and Drug Safety (20173MFDS162).