Method development, validation, and application of liquid chromatography-electrospray ionization-mass spectrometry/mass spectrometry method for the quantification of amprenavir in plasma samples

Bandaru Anil Kumar Bomma Ramesh Shankar Cheruku D.V.R.N. Bhikshapathi   

Open Access   

Published:  Jun 19, 2022

Abstract

A specific liquid chromatography-mass spectrometry/mass spectrometry spectrometric procedure for the quantitation of amprenavir drug in biological matrices was developed and validated. Chromatographic isolation was accomplished through a Zorbax C18 analytical stationary phase having the dimensions of 50 mm × 4.6 mm and particle size of 5.0 μm. Isocratic separation was processed with acetonitrile 0.1%v/v HCOOH in water and methyl alcohol in the proportion of 60:10:30 as a moveable system with a flow rate of 0.60 mL/min. Liquid–liquid extraction was carried out for drug and internal standard isolation with an ethyl acetate solvent. Parent and product ionic components were examined at m/z 506.2 → 89.1 for amprenavir and 367.1 → 350.1 for rilpivirine internal standard on the MRM (multiple reaction monitoring) mode. The linearity plot of analyte was rectilinear in the concentration over 0.15–1500 ng/mL with the correlation coefficient value of r2 being >0.990. %relative standard deviation findings were <4.21% for intraday and interday accuracy and precision. The technique has good recoveries, and %recovery findings of LQC (low quality control), MQC(median quality control), and HQC (high quality control) solutions were 92.9%, 95.1%, and 96.4%, respectively. Amprenavir has more stability for longer time when subjected to different stability environments and the procedure was efficiently relevant to the regular investigation of amprenavir analyte in the biological matrix.


Keyword:     Amprenavir protease inhibitor LC-MS/MS sensitivity and linearity.


Citation:

Bandaru AK, Bomma R. Method development, validation, and application of liquid chromatography-electrospray ionization-mass spectrometry/mass spectrometry method for the quantification of amprenavir in plasma samples. J Appl Pharm Sci, 2022; 12(07):115–121.

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

HTML Full Text

Reference

Brophy DF, Israel DS, Pastor A, Gillotin C, Chittick GE, Symonds WT, Lou Y, Sadler BM, Polk RE. Pharmacokinetic interaction between amprenavir and clarithromycin in healthy male volunteers. Antimicrob Agents Chemother, 2000; 44(4):978-84. https://doi.org/10.1128/AAC.44.4.978-984.2000

Cha YJ, Song YK, Chae SH. Development and validation of an LC-MS/MS method for monitoring larotrectinib, a tropomyosinrelated kinase inhibitor, in mouse and human plasma and application to pharmacokinetic studies. J Anal Sci Technol, 2020; 11:20. https://doi.org/10.1186/s40543-020-00219-5

Chambers EE, Woodcock MJ, Wheaton JP. Systematic development of an UPLC-MS/MS method for the determination of tricyclic antidepressants in human urine. J Pharm Biomed Anal, 2014; 88:660-5. https://doi.org/10.1016/j.jpba.2013.09.001

Dandache S, Sevigny G, Yelle J, Stranix BR, Parkin N, Schapiro JM, Wainberg MA, Wu JJ. In vitro antiviral activity and cross-resistance profile of PL-100, a novel protease inhibitor of human immunodeficiency virus type 1. Antimicrob Agents Chemother, 2007; 51(11):4036-43. https://doi.org/10.1128/AAC.00149-07

European Medicines Agency. Guideline on bioanalytical method validation, 2011. https://www.ema.europa.eu/en/documents/scientificguideline/guideline-bioanalytical-method-validation_en.pdf.

El-Zaher AA, Hashem HA, Elkady, Allam MA. A validated LC-MS/MS bioanalytical method for the simultaneous determination of dapagliflozin or saxagliptin with metformin in human plasma. Microchem J, 2019; 149:104017. https://doi.org/10.1016/j.microc.2019.104017

Elawadya T, Khedrb A, El-Enanya N, Belala F. LC-MS/MS determination of erdafitinib in human plasma after SPE: Investigation of the method greenness. Microchem J, 2020; 154:104555. https://doi.org/10.1016/j.microc.2019.104555

Granfors MT, Wang JS, Kajosaari LI, Laitila J, Neuvonen PJ, Backman JT. Differential inhibition of cytochrome P450 3A4, 3A5 and 3A7 by five human immunodeficiency virus (HIV) protease inhibitors in vitro. Basic Clin Pharmacol Toxicol, 2006; 98(1):79-85. https://doi.org/10.1111/j.1742-7843.2006.pto_249.x

Henion J, Brewer E, Rule G. Sample preparation for LC/MS/MS: knowing the basic requirements and the Big Picture of an LC/MS system can ensure success in most instances. Anal Chem, 1998; 70:650A-6A. https://doi.org/10.1021/ac981991q

ICH guidelines for validation of analytical procedures: text and methodology. Q2(R1) ICH, Geneva, Switzerland,pp 1-14, 2005.

Jingduan Chi, Anura L Jayewardene, Judith A. Stone, Toshiro M, Francesca TA. Simultaneous determination of five HIV protease inhibitors nelfinavir, indinavir, ritonavir, saquinavir and amprenavir in human plasma by LC/MS/MS. J Pharm Biomed Anal, 2002; 30:675-84. https://doi.org/10.1016/S0731-7085(02)00357-6

Logoyda LS. LC-MS/MS Method development and validation for the determination of nifedipine in human plasma. Biointerf Res Appl Chem, 2020; 10(5):6189-96. https://doi.org/10.33263/BRIAC105.61896196

Murphy AT, Kasper SC, Gillespie TA, DeLong AF. Determination of xanomeline and active metabolite, n-desmethylxanomeline, in human plasma by liquid chromatography-atmospheric pressure chemical ionization mass spectrometry. J Chromatogr B Biomed Appl, 1995; 668:273-80. https://doi.org/10.1016/0378-4347(95)00080-3

Padmini T, Satyanarayana L. Spectrophotometric determination of amprenavir by complex formation in bulk drug and formulation samples. Int J Pharm Clin Res, 2017; 9:521-4.

Patel DS, Sharma N, Patel MC. Development and validation of a selective and sensitive LC-MS/MS method for determination of cycloserine in human plasma: application to bioequivalence study, J Chromatogr B, 2011; 879:2265-73. https://doi.org/10.1016/j.jchromb.2011.06.011

Rajitha K, Lakshmi Prasanna N, Naveen R, Ranjith CH, Ashok Kumar A. A rapid RP-HPLC method development and validation for the quantitative estimation of indinavir in capsules. Int J Pharm Pharma Sci, 2014; 6:453-6.

Sadler BM, Hanson CD, Chittick GE, Symonds WT, Roskell NS. Safety and pharmacokinetics of amprenavir (141W94), a human immunodeficiency virus (HIV) type 1 protease inhibitor, following oral administration of single doses to HIV-infected adults. Antimicrob Agents Chemother, 1999; 43(7):1686-92. https://doi.org/10.1128/AAC.43.7.1686

Samson ID, Etsay W, Yemane B. LCMS/MS method development and validation for the quantification of amprenavir in human plasma. J Glob Trends Pharm Sci, 2015; 6(2):2500-5.

Singh N, Bansal P, Maithani M, Chauhan Y. Development and validation of novel LC-MS/MS method for determination of Lusutrombopag in rat plasma and its application to pharmacokinetic studies. Arab J Chem, 2020; 13(2):4162-9. https://doi.org/10.1016/j.arabjc.2019.06.014

US FDA. Guidance for Industry Bioanalytical Method Validation, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, MD, 2001.

Wittayanarakul KL. Precise predictions of protonate states as a prerequisites for consistent MM-PB(GB)SA necessary free energies calculation of HIV-I protease inhibitor. J Comp Chem, 2008; 29(5):673-85. https://doi.org/10.1002/jcc.20821

Zhou SF, Zhou ZW, Yang LP, Cai JP. Substrates, inducers, inhibitors and structure-activity relationships of human Cytochrome P450 2C9 and implications in drug development. Curr Med Chem, 2009; 16(27):3480-675. https://doi.org/10.2174/092986709789057635

Article Metrics

0 Absract views 0 PDF Downloads 0 Total views

   Abstract      Pdf Download

Related Search

By author names

Citiaion Alert By Google Scholar

Name Required
Email Required Invalid Email Address

Comment required