RP-HPLC Method Development And Validation Of Tetrabenazine With Its Known And Unknown Degra-dation Impurities In Its Tablet Dosage Form

Authors

  • Lavina Rajawat Shree Swaminarayan Sanskar Pharmacy College, Gandhinagar, Gujarat, India.
  • Jigna T Patel Shree Swaminarayan Sanskar Pharmacy College, Gandhinagar, Gujarat, India.
  • Chirag J Patel Shree Swaminarayan Sanskar Pharmacy College, Gandhinagar, Gujarat, India.
  • M. M. Patel Shree Swaminarayan Sanskar Pharmacy College, Gandhinagar, Gujarat, India.

Keywords:

Tetrabenazine, RP-HPLC, Forced degradation, Related substances, Development & Validation

Abstract

Force degradation also known as Stress testing. It’s process i.e. involves degradation of drug product and drug substance at condition more than accelerated condition & thus generates degradation products i.e. can be studied to determine the stability of the molecule. In the present study gradient RP-HPLC method was development for separation of impurities and degradation product from drug product. The chromatographic separation was performed on Inertsil ODS 3V (250 mm x 4.6 mm, 5 µm) using gradient elution. Other HPLC parameter which were optimised flow rate 1.0 ml/min; detection wavelength 224 nm; column oven temperature 25ºC; and injection volume 20 µl. The development method was statistically validated for linearity (1.2-6.0ppm). The Forced degradation study revealed that drug was sensitive to Peroxide degradation, in other condition not adequate degradation observed. Result of precision (% RSD ? 5), accuracy, specificity are well within the limits. % Recovery at 50%, 100%, 150% was found to be within limits 70-130%.

Downloads

Download data is not yet available.

References

“Tetrabenazine Drug Profile” September 2017, https://www.drugbank.ca/drugs/DB04844

“Tetrabenazine Drug Profile” September 2017, https://pubchem.ncbi.nlm.nih.gov/compound/tetrabenazine#section=Top

“Tetrabenazine Drug Profile” September 2017, http://www.chemspider.com/Chemical-Structure.5796.htm

SethiPD, HPLC Quantitative Analysis of Pharmaceutical Formulations, 3rdEdn, CBS Publication and Distributors New Delhi, 2001,pp 1-20, 99-105.

U.S. EPA, Guidance for Method development and Method Validation for the Resource Conservation and Recovery Act (RCRA) Program.1995, www.epa.gov/sw 846/pdfs/methdev.pdf

Hamilton RJ, Sevell PA, Introduction to HPLC, 2ndEdn, Chapman and Hall London Publication 1982, pp 189.

Beckett A.H, and Stenlake J. B, Practical Pharmaceutical Chemistry, 1stEdn, CBS Publishers and Dis-tributors New Delhi, 2004, pp 275-325.

Dr. S. Ravi Shankar, Textbook of Pharmaceutical Analysis, 3rdEdn, RX Publication, 2014, pp13.1, 13.3, 18.2 and 18.5.

Vogel’s, Textbook of Quantitative Chemical Analysis, 5th Edn, Pearson Education Limited Publication, 1996, pp 645-651, 752-755.

Sharma S, Sher P, Badve S, Atmaram P.P, Recent Advances in Spectroscopic techniques, 6thEdn, AAPS Pharm Science Technology Publication,2005, pp 618-625.

ICH Harmonized tri partitle guideline, Validation of Analytical Procedures: Text and Methodology, Q2 (R1), 2005, pp 8-17.

Ahuja s, and Dong MW, Handbook of Pharmaceutical Analysis by HPLC, 1stEdn, Elsevier Academic Press, United Kingdom, 2005, pp 62-68.

Singh SS and Bakshi M, Development of validated stability indicating assay methods: critical review. Journal of Pharmaceutical and biomedical analysis, April 2002, pp11–40.

Schirmer RE, Modern Methods of Pharmaceutical Analysis, CRC Press Inc, 1982, pp61-138.

Cartenson JT, and Swarbirck J, Solution kinetics-Drug stability principles and practice, 2ndEdn, Marcel Dekker series, 1995, pp 17-90.

Stability Testing of New Drugs and Product:ICH Q1 A (R2). 2003, pp 1-20.

Charde MS, Kumar J, Welankiwar AS and Chakole RD, Review: development of forced degradation studies of drugs. Int J of Advances in P’ceutics,December 2013, pp34-38.

Validation of Analytical Procedure: Text and Methodology ICH, Q2 (R1).2005, pp 1-13.

Patel PMM N, Mehta I, Patel CJ, Stability Indicating Method For the Simultaneous Estimation of Cefuroxime Axetil and Linezolid in Pharmaceutical Dosage Forms. International Journal of Pharmaceutical & Drug Analysis, 2017, 5(12), pp456-466.

Hotha KK, Reddi SK, Raju VK and Ravindranath LK, Forced degradation studies: practical approach- overview of regulatory guidance and literature for the drug substances and drug products. Int Research J of Pharm, July2013, pp78-83.

Published

2018-04-19
Statistics
68 Views | 43 Downloads
Citatons

How to Cite

Lavina Rajawat, Jigna T Patel, Chirag J Patel, and M. M. Patel. “RP-HPLC Method Development And Validation Of Tetrabenazine With Its Known And Unknown Degra-Dation Impurities In Its Tablet Dosage Form”. International Journal of Pharmaceutics and Drug Analysis, vol. 6, no. 4, Apr. 2018, pp. 453-6, https://ijpda.com/index.php/journal/article/view/390.

Issue

Section

Research Articles
Share |