Bioanalytical Method Development and Validation for Quantitative Estimation of Valsartan by LC-MS/MS in Human Plasma

Krishna Chinthala; Prasad Kancherla; Pramod Kumar

doi:10.14233/ajchem.2017.20531

Issue

Vol. 29 No. 7 (2017): Vol 29 Issue 7

Issue Published : May 13, 2017

This work is licensed under a Creative Commons Attribution 4.0 International License.

Bioanalytical Method Development and Validation for Quantitative Estimation of Valsartan by LC-MS/MS in Human Plasma

https://doi.org/10.14233/ajchem.2017.20531

Krishna Chinthala

Environmental Protection Training and Research Institute, 91/4, Gachibowli, Hyderabad-500 032, India

Prasad Kancherla

Centre for Chemical Sciences and Technology, Institute of Science & Technology, Jawaharlal Nehru Technological University Hyderabad, Kukatpally, Hyderabad-500 085, India

Pramod Kumar

Centre for Chemical Sciences and Technology, Institute of Science & Technology, Jawaharlal Nehru Technological University Hyderabad, Kukatpally, Hyderabad-500 085, India

Corresponding Author(s) : Krishna Chinthala

krishfdg@gmail.com; lalubpharm@gmail.com

Asian Journal of Chemistry, Vol. 29 No. 7 (2017): Vol 29 Issue 7
Article Published : May 13, 2017

Abstract

An accurate, precise LC-MS/MS method has been developed and validation for quantitative estimation of valsartan using irbesartan as internal standard in human plasma. The method was established based on the HPLC separation on Zorbax SB-C₁₈, 4.6 × 50 mm, 5 μm (Make: Agilent technologies) column at 40 °C using HPLC methanol: 0.1 % formic acid (80:20, v/v) at a flow rate of 1 mL/min. The total chromatographic run time was 2.5 min with retention time of 1.40 min for valsartan. All quality control samples of analytes and internal standard was detected with LC-MS/MS system in multiple reactions monitoring mode. The method was validated according to USFDA guidelines. The calibration curves obtained were found to be linear over the concentration range of 50.85 to 12046.60 ng/mL. Recovery studies were conducted for spiked plasma samples and mean % recoveries were ranged from 75.39-79.44 %. The results of within the batch and between the batch precision and accuracy were found within the limits of acceptance. The proposed LC-MS/MS method can successfully applied for the pharmacokinetic studies.

Keywords

Valsartan LC-MS/MS Bioanalytical Irbesartan

Chinthala, K., Kancherla, P., & Kumar, P. (2017). Bioanalytical Method Development and Validation for Quantitative Estimation of Valsartan by LC-MS/MS in Human Plasma. Asian Journal of Chemistry, 29(7), 1482–1486. https://doi.org/10.14233/ajchem.2017.20531

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References

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M.J. O’ Neil, A. Smith, P.E. Heckelman and J.F. Kinneary, The Merck Index: An Encyclopedia of Chemicals, Drugs and Biologicals, edn 14, p. 1767 (2006).

Matrindale, The Complete Drug Reference, Pharmaceutical Press, London, Chicago, edn 34, p. 1018 (2002).

J.H. Bauer and G.P. Reams, Arch. Intern. Med., 155, 1361 (1995); https://doi.org/10.1001/archinte.1995.00430130027004.

G. Flesch, P. Müller and P. Lloyd, Eur. J. Clin. Pharmacol., 52, 115 (1997); https://doi.org/10.1007/s002280050259.

R.L. Webb and M. de Gasparo, Exp. Clin. Cardiol., 6, 215 (2001).

C.D. Benge and J.A. Muldowney III, Expert Opin. Drug Metab. Toxicol., 8, 1469 (2012); https://doi.org/10.1517/17425255.2012.725721.

R.N. Sharma and S.S. Pancholi, Acta Pharm., 62, 45 (2012); https://doi.org/10.2478/v10007-012-0004-3.

T.S. Kepekci, J. Anal. Methods Chem., 179, 627 (2013).

G. Iriarte, O. Gonzalez, N. Ferreirós, M.I. Maguregui, R.M. Alonso and R.M. Jiménez, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 877, 3045 (2009); https://doi.org/10.1016/j.jchromb.2009.07.018.

S.S. Imam, A. Ahad, M. Aqil, Y. Sultana and A. Ali, J. Pharm. Bioallied Sci., 5, 61 (2013).

D.U. Vinzuda, G.U. Sailor and N.R. Sheth, Int. J. ChemTech Res., 2, 1461 (2010).

S. Ghanty, R. Das, S. Maiti and K.K. Sen, J. Pharm. Sci. Technol., 3, 88 (2014).

H.J. Shah, N.B. Kataria, G. Subbaiah and C.N. Patel, Chromatographia, 69, 1055 (2009); https://doi.org/10.1365/s10337-009-0950-1.

N. Koseki, H. Kawashita, H. Hara, M. Niina, M. Tanaka, R. Kawai, Y. Nagae and N. Masuda, J. Pharm. Biomed. Anal., 43, 1769 (2007); https://doi.org/10.1016/j.jpba.2006.12.030.

S.G. Gadepalli, P. Deme, M. Kuncha and R. Sistla, J. Pharm. Anal., 4, 399 (2014); https://doi.org/10.1016/j.jpha.2013.12.003.

A.V. Ramani, P. Sengupta and R. Mullangi, Biomed. Chromatogr., 23, 615 (2009); https://doi.org/10.1002/bmc.1161.

H. Li, Y. Wang, Y. Jiang, Y. Tang, J. Wang, L. Zhao and J. Gu, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 852, 436 (2007); https://doi.org/10.1016/j.jchromb.2007.02.014.

P.S. Selvan, K.V. Gowda, U. Mandal, W.D. Solomon and T.K. Pal, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 858, 143 (2007); https://doi.org/10.1016/j.jchromb.2007.08.016.

M. Levi, G. Wuerzner, E. Ezan and A. Pruvost, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 877, 919 (2009); https://doi.org/10.1016/j.jchromb.2009.02.030

Issue

Vol. 29 No. 7 (2017): Vol 29 Issue 7

Bioanalytical Method Development and Validation for Quantitative Estimation of Valsartan by LC-MS/MS in Human Plasma

Corresponding Author(s) : Krishna Chinthala

Abstract

Keywords

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