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


  • 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.


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


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%.


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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.



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