ISSN : 2348 - 8948

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Volume : 6 Issue :4 Month : April (2018)
Page Numbers : 453-463

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

Lavina Rajawat*, Jigna T Patel, Chirag J Patel, M. M. Patel
Force degradation also known as Stress testing. Its 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 m) using gradient elution. Other HPLC parameter which were optimised flow rate 1.0 ml/min; detection wavelength 224 nm; column oven temperature 25C; and injection volume 20 l. 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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