Abstract

STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION FOR RASAGILINE IN ITS PHARMACEUTICAL DOSAGE FORM

Mona Christian,* and Dr. B. N. Suhagia

Abstract

A new simple, rapid and sensitive stability indicating RP-HPLC method has been developed for the determination of Rasagaline in its pharmaceutical dosage form. The method employs Zorbax Extend C18, 150x4.6mm, 5μ(Agilent) column for the chromatographic separation and phosphate buffer: ACN (40:60, v/v) was used as a mobile phase. Separation was completed within 10 min with a flow rate of 1 ml/min and detection was at 264 nm. The retention time of Rasagaline was found to be 4.65 min. The proposed method was found to have the linearity in the concentration range of range of 10-30 μg/ml. Linearty regression coefficient was not less than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 99.02 – 102.30% of Rasagaline mesaylate. LOD and LOQ were found to be within limit. The results obtained on the validation parameters met ICH Guidelines. The method was found to have suitable application in routine laboratory analysis with high degree of accuracy and precision.

Keywords: Rasagaline, RP-HPLC Estimation, Analytical Method Validation.