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Current Trends in Science and Technology

an Open Access Publication ISSN: 0976-9730 | 0976-9498

Pharmaceutical Sciences

Bioanalytical Method Development and Validation for Estimation of Tizanidine in K2edta Human Plasma by Using LC-MS/MS

Ashish Kumar Gupta
Assistant Professor, Department of Pharmacy, V.B.S. Purvanchal University Jaunpur U.P.
Minakshi Verma
Assistant Professor, Department of Pharmacy, G.S.V.M. Medical College Kanpur U.P.
Online First: March 10, 2018
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Abstract

Bioanalytical method Validation employed for quantitative determination of drug and their metabolites in biological fluids. Comprises all criteria determining data quality, such as selectivity, accuracy, precision, recovery and senstivity. The main purpose of method validation is to demonstrate that a specific Bioanalytical method can reliably determine the concentration of drug in study sample with high degree of confidence. Validation does not means that method is perfect, but validation means method has met a set of criteria to ensure that it is reliable and consistent. Tizanidine is a central alpha 2 adrenergic agonist –inhibits release of excitatory amino acid in the spinal interneurones. It may facilitate the inhibitory transmitter glycine as well. It inhibits polysyneptic reflexes reduce muscle tone and frequency of muscle spasms without reducing muscle strength.


Following oral administration, tizanidine is essentially completely absorbed .The absolute oral bioavailability of tizanidine is approximately 40%,due to extensive first-pass hepatic metabolism. Tizanidine is extensively distributed throughout the body with a mean steady state volume of distribution of 2.4 L/kg following intravenous administration in healthy adult volunteers tizanidine is approximately 30% bound to plasma proteins.

Keyword : Bioanalytical method Validation, LC-MS/MS, Human Plasma, Tizanidine, HPLC.

  Submitted
Mar 10, 2018
Published
Mar 10, 2018
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References

1. Thompson M, Ellison SLR, Wood R. Harmonised Guidelines for Single Laboratory Validation of Method of Analysis. Pure Appl Chem. 2008;74:835–55. 2. Wood R. How to Validate Analytical Methods. Trends Analyt Chem. 2005;18:624–132. 3. McDowall RD. The Role of Laboratory Information Management Systems LIMS in Analytical Method Validation.Anal ChimActa. 2007;54:149–58. 4. Vander HY, Nijhuis A, Verbeke JS, Vandeginste BG, Massart DL.Guidance for rubustness/ruggedness test in method validation.J Pharm Biomed Anal. 2009;24:723–53. 5. Puluido A, Ruusanches I, Boque R, Rius FX. Uncertainty of results in routine Qualitative Analysis in Analytical Chemistry.J Pharm Biomed Anal. 2005;22:647–54. 6. Kallner A. Quality specification based on the uncertainty of measurement. Scand J Lab Invest. 2005;59:513–6. 7. Jhanf J, Chang CC, Fink DJ, Kroll MH. Evaluation of linearity in clinical Laboratory. Arch PatholLab Med. 2004;128:44–8. 8. Mark H. Application of improved procedure for testing linearity of analytical method to pharmaceutical analsysis. J Pharm Biomed Anal. 2003;33:7–20. 9. Trullols E, Ruisanchez I, Rius FX. Trends in Analytical Chemistry. J Lab Invest. 2003;23:137–45. 10. Valcarcel M, Cardenas S, Gallego M. Sample Screening system in analytical chemistry. Trends Analyt Chem. 1999;23:137–45.
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References

1. Thompson M, Ellison SLR, Wood R. Harmonised Guidelines for Single Laboratory Validation of Method of Analysis. Pure Appl Chem. 2008;74:835–55.
2. Wood R. How to Validate Analytical Methods. Trends Analyt Chem. 2005;18:624–132.
3. McDowall RD. The Role of Laboratory Information Management Systems LIMS in Analytical Method Validation.Anal ChimActa. 2007;54:149–58.
4. Vander HY, Nijhuis A, Verbeke JS, Vandeginste BG, Massart DL.Guidance for rubustness/ruggedness test in method validation.J Pharm Biomed Anal. 2009;24:723–53.
5. Puluido A, Ruusanches I, Boque R, Rius FX. Uncertainty of results in routine Qualitative Analysis in Analytical Chemistry.J Pharm Biomed Anal. 2005;22:647–54.
6. Kallner A. Quality specification based on the uncertainty of measurement. Scand J Lab Invest. 2005;59:513–6.
7. Jhanf J, Chang CC, Fink DJ, Kroll MH. Evaluation of linearity in clinical Laboratory. Arch PatholLab Med. 2004;128:44–8.
8. Mark H. Application of improved procedure for testing linearity of analytical method to pharmaceutical analsysis. J Pharm Biomed Anal. 2003;33:7–20.
9. Trullols E, Ruisanchez I, Rius FX. Trends in Analytical Chemistry. J Lab Invest. 2003;23:137–45.
10. Valcarcel M, Cardenas S, Gallego M. Sample Screening system in analytical chemistry. Trends Analyt Chem. 1999;23:137–45.
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