Advancements in RP-HPLC Methodology for Tirzepatide Estimation in Human Plasma: Development, Validation, and Applications
DOI:
https://doi.org/10.22270/ajprd.v13i3.1579Abstract
Reversed-phase high-performance liquid chromatography (RP-HPLC) is a technique that separates molecules by polarity. It's commonly used in pharmaceutical development and manufacturing, as well as in proteomic research. The goal of the proposed method is to develop and validate a new green and simple liquid chromatographic system for simultaneously quantifying the novel drug terzepatide. A simple, specific, precise and accurate method for quantification of tirzepatide was developed and validated in human plasma and was applied for pharmacokinetics to determination the concentration of tirzepatide in human low dose with different formulation of the tirzepatide. Although, several methods have been developed previously for this drug as reported, but this is the -cost, fast and more accurate as the samples have been prepared by less costly chemicals and procedures, like protein precipitation technique also, use of nitrogen for drying has shown better results compared to earlier methods.
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Mir KB, Abrol V, Wani TU, Jan I, Singh N, Khan NA, Dar AA, Sultan RMS, Lone SA, Iesa MAM, Alhag SK, Al-Shuraym LA, Helm N, Al-Farga A. Validation and development of RP-HPLC method for quantification of glibenclamide in rat plasma and its application to pharmacokinetic studies in wistar rats. Heliyon. 2023; 9(11):e20876.
American Diabetes Association. Gestational diabetes mellitus. Diabetes Care. 2004; 27(Suppl 1):S88.
Bastaki S. Diabetes mellitus and its treatment. Int J Diabetes Metab. 2005; 13(3):111–134.
Rani V, Deep G, Singh RK, Palle K, Yadav UC. Oxidative stress and metabolic disorders: pathogenesis and therapeutic strategies. Life Sci. 2016;148:183–193.
Barnett AH. Diabetes and hypertension. Br Med Bull. 1994; 50(2):397–407.
Krentz AJ, Ferner RE, Bailey CJ. Comparative tolerability profiles of oral antidiabetic agents. Drug Saf. 1994; 11(4):223–241.
Ahmad A, Khan R, Alkharfy K. Development and validation of RP-HPLC method for simultaneous estimation of glibenclamide and thymoquinone in rat plasma and its application to pharmacokinetics. Acta Chromatogr. 2015; 27(3):435–448.
Wani TU, Mir KB, Raina A, Dar AA, Jan I, Khan NA, Wani TA, Sofi JA, Hassan G, Almoallim HS. Simultaneous quantification of losartan potassium and its active metabolite, EXP3174 in rabbit plasma by validated HPLC-PDA. Biomed Chromatogr. 2023; 37(8):e5645.
Jan I, Dar AA, Wani AA, Mukhtar M, Sofi JA, Hassan G. Risk assessment, development and validation of a GC-ECD-based method for the quantification of cypermethrin from green pea. Biomed Chromatogr. 2022; 36(7):e5373.
Bhat MH, Fayaz M, Kumar A, Dar AA, Jain AK. Chromatographic method for determination of the amino acid content in Dioscoreabulbifera L. tubers by RP-HPLC. Pharm Sci. 2019;25(1):65–69.
International Conference on Harmonisation. Validation of analytical procedures: text and methodology Q2(R1). ICH Harmonised Tripartite Guideline. 2005;1(20):5.
Dar AA, Sangwan PL, Singh N, Kumar A. Method validation and simultaneous quantification of five triterpenoids from Codonopsis ovata by high-performance thin-layer chromatography. J Planar Chromatogr Mod TLC. 2019; 32(3):251–256.
Dar AA, Raina A, Kumar A. Development, method validation and simultaneous quantification of eleven bioactive natural products from high-altitude medicinal plant by high-performance liquid chromatography. Biomed Chromatogr. 2022; 36(8):e5408.
Dar AA, Sangwan PL, Khan I, Gupta N, Qaudri A, Tasduq SA, Kitchlu S, Kumar A, Koul S. Simultaneous quantification of eight bioactive secondary metabolites from Codonopsis ovata by validated high-performance thin-layer chromatography and their antioxidant profile. J Pharm Biomed Anal. 2014; 100:300–308.
U.S. Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation. 2001.
Sofi JA, Dar AA, Jan I, Hassan G, Dar SR, Mughal AH, Dar NA. Development and validation of GC-ECD method using QuEChERS for pesticide residue determination in cucumber. Biomed Chromatogr. 2023:e5647.
Singh N, Dar AA, Kumar A. A simple and efficient approach for the synthesis of 1, 3-oxazolidines from β-amino alcohols using grinding technique. Chemistry Select. 2018; 3(48):13675–13681.
Bhat MH, Fayaz M, Kumar A, Dar AA, Jain AK. Development of an efficient micropropagation system for Dioscoreabulbifera L. and phytochemical profile of regenerated plants. J Genet Eng Biotechnol. 2022; 20(1):107.
International Conference on Harmonisation. Validation of analytical procedures: text and methodology Q2(R1). Geneva, Switzerland: ICH; 2005
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