DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF FOSNETUPITANT AND PALONOSETRON IN PHARMACEUTICAL DOSAGE FORM
Dr. Pallapati Suman*
ABSTRACT
The present work concerns with the development of stability indicating the RP-HPLC method for simultaneous determination of Fosnetupitant (FTP) and Palonosetron (PNS). In the developed RP-HPLC method separation was achieved using Synchronies C-18 (250mm x 4.6mm, 5μm) column as a stationary phase and Methanol: Acetonitrile: 1% sodium perchlorate 75:20:05 (v/v/v) as a mobile phase at pH 4. The retention times of FTP and PNS were found to be 5.3 min and 9.3 min, respectively with run time 16 min. Calibration curves were drawn relating the integrated area under peak to the corresponding concentrations of FTP and PNS in the range of 94-329 μg/ml and 01-035 μg/ml, respectively. The developed method has been validated and met the requirements delineated by ICH guidelines with respect to linearity, accuracy, precision, specificity and robustness. Both the drugs were subjected to acid, base hydrolysis, peroxide, UV light and thermal degradation conditions. Degradation peak was well resolved from the main peak of drug. The validated method was successfully applied for determination of the studied drugs in formulation and moreover its results were statistically compared with those obtained by the official method and no significant difference was found between them.
Keywords: Fosnetupitant, Palonosetron, RP-HPLC, ICH guidelines, Method Validation.
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