Abstract
Abstract
Background
Recent advances in the diversified anti-diabetic drugs have appeared in the startling increase in the count of poisoning cases. The epidemics of diabetes mellitus are increasing; hence, the no. of anti-diabetic drug users raised by 42.9%. The use of glimepiride raised to 24%. As the toxicity and drug cases are also escalating with increasing epidemics of diabetes mellitus, a novel gas chromatography-mass spectrometry (GC-MS) method for detecting glimepiride in biological matrices is developed.
Results
Liquid-liquid extraction method was employed by using 1-butanol: hexane (50:50, v/v) under an alkaline medium, and then back extraction was done via acetic acid. Distinct derivatization techniques were employed for the sample preparation for GC-MS analysis, i.e., silylation and acylation. Derivatization approaches were optimized under different parameters, i.e., reaction temperature and reaction time. N-Methyl-N-(trimethylsilyl) trifluoroacetamide [MSTFA] was found to be the best sound derivatization reagent for the GC-MS analysis of glimepiride. Total ion current (TIC) mode was selected for the monitoring of ions of trimethylsilyl (TMS) derivative of glimepiride with an m/z ratio of 256. Distinct parameters like specificity, carryover, stability, precision, and accuracy were evaluated for validating the identification method. The GC-MS method is found to be linear and illustrated within the range 500 to 2500 ng/ml with the value of R2 (coefficient of determination) at 0.9924. The stability of the extracted and derivatized glimepiride was accessed with regard to processed/extracted sample conditions and autosampler conditions, respectively. Accuracy at each concentration level was within the + 15% of the nominal concentration. Precision (%) for the interday and intraday analysis was found to be in the respectable spectrum.
Conclusion
Henceforth, the proposed GC-MS method can be employed for the determination of glimepiride in biological matrices.
Publisher
Springer Science and Business Media LLC
Subject
Law,Health(social science),Pathology and Forensic Medicine
Reference27 articles.
1. Box, Meridian Road P O et al (2020) Acylation derivatization reagents. Pierce 1–6. http://www.cromlab.es/Articulos/Catalogos/Catalogos_Thermo/Manuales_Pierce/TFAA,%20PFAA,%20HFAA,%20TFAI,%20HFBI,%20MBTFA.pdf. Accessed 12 Oct 2020.
2. Chounta A et al (2005) Cholestatic liver injury after glimepiride therapy. J Hepatol 42(6):944–946
3. Dhole SM, Khedekar PB, Amnerkar ND (2013) Development and validation of hptlc densitometry method for simultaneous estimation of rosiglitazone and glimepiride in fixed tablet dosage form. J Chil Chem Soc 58(2):1663–1666
4. Dubey P, Shukla SK, Gupta KC (2013) Modified Scott’s test for ketamine hydrochloride. Aust J Forensic Sci 45(2):165–171
5. Fda, and Cder. 2018. Bioanalytical method validation guidance for industry biopharmaceutics bioanalytical method validation guidance for industry biopharmaceutics contains nonbinding recommendations. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm (May 3, 2020)
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