Development of newer validated HPLC method for the determination of Alvimopan in Rat plasma

International Journal of Pharmacy and Biomedical Engineering

© 2020 by SSRG - IJPBE Journal

Volume 7 Issue 3

Year of Publication : 2020

Authors : Soundaryashree NR, Majumdar Manish, Sunitha HB

10.14445/23942576/IJPBE-V7I3P102

How to Cite?

Soundaryashree NR, Majumdar Manish, Sunitha HB, "Development of newer validated HPLC method for the determination of Alvimopan in Rat plasma," SSRG International Journal of Pharmacy and Biomedical Engineering, vol. 7,  no. 3, pp. 4-14, 2020. Crossref, https://doi.org/10.14445/23942576/IJPBE-V7I3P102

Abstract:

A simple, precise, rapid and accurate RP-HPLC method was developed for the estimation of Alvimopan in rat plasma. The drug samples were extracted by protein precipitation method with methanol as a solvent. The separation was achieved by using C-18 Eclipse plus (5µ particle size, 250×4.6mm, 5µm internal diameter). The mobile phase comprises of potassium dihydrogen orthophosphate buffer of pH 3.0 adjusted with orthophosphoric acid and acetonitrile in the ratio of 70:30(v/v). The flow rate was 1.0ml/min and the effluents were monitored at 220 nm with a total run time of 10min. The retention time was found to be 6.66. The detection concentration was linear over 25-150µg/ml. Regression equation of Alvimopan was found to be y = 26407x+891423 with regression coefficients 0.999 and percentage recovery of 99.07%. The liquid chromatography method was extensively validated for linearity, accuracy, precision, LOD, LOQ.
All these analytical validation parameters were observed to be satisfactory, the developed method was successfully demonstrated for the determination of Alvimopan in rat plasma and validated in accordance to ICH guidelines. Hence, this method can be convieniently adopted for the analysis of rat plasma for the application in pharmacokinetic study, drug interaction, bio availability and bio equivalence.

Keywords:

Alvimopan, RP-HPLC, Methanol, Acetonitrile, Phosphate buffer pH 3, Rat plasma.

References:

[1] Kamboj PC. Pharmaceutical Analysis. Vol. I. 2nd ed. New Delhi: Vallabh Publications; 2007. Pp 1-2.
[2] SethiPD,High performance liquid chromatography. CBS publishers and distributors, New Delhi 2010. Pg no 3-4.
[3] Kealey D, Haines PJ. Instant Notes Analytical Chemistry. 1st ed. Taylor & Franchise e library; 2005. Pg no 119-30.
[4] www.en.wikipedia.org/wiki/alvimopan
[5] www.drug.ca/drug/DB06274
[6] Azodo IA, Ehrenpreis ED. Alvimopan (Adolor/GlaxoSmithKline). Curr Opin investing Drugs. 2002; 3: 1496-501.
[7] https://medlineplus.gov/druginfo/meds/a608051.html
[8] Michael E, Schartz IS, Krull. Analytical method development and validation. Japan: Elsevier Science; 2001;25-46.
[9] U.S Department of Health and Human Services, Food and Drug Administration. Guidance for Industry, Bio analytical Method Validation, May2001.
[10] Padmini T, Satyanarayana L. HPLC method development and validation for the simultaneous estimation of Alvimopan in bulk and pharmaceutical dosage form. Int J Curr Res. 2018;10(1): 63854-56.
[11] Sarasambi PS, Faheem A, Sonawane A, Gowrisankar D. Reverse phase-HPLC method for the analysis of naltrexone hydrochloride in bulk drug and its pharmaceutical formulations. Scholars research library. 2010; 2(2):294-9.
[12] Beattie DT. Safety and efficacy update: Alvimopan in postoperative ileus. Clinical medicine: therapeutics.2009; 1(1):199-213.
[13] Sandiya S, Alvimopan a novel peripheral opioid receptor antagonist. Indian J Pharmacolo. 2006; 38(6):442-4.
[14] ICH, Q2B, Validation of analytical procedures: Methodology, International Conference Harmonization, Geneva, November 1996. Pp 1-8.
[15] Edward AI, Savoie LM, Hanna JA, Apostolides YG. Alvimopan addition to a standard perioperative recovery Pathway. JSLS 2011; 15:492–98.