DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR PACLITAXEL IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM
Journal Title: Int J of Preclin & Pharm Res - Year 2013, Vol 3, Issue 2
Abstract
ABSTRACT A simple, precise, rapid and accurate reverse phase HPLC method has been developed for the determination of Paclitaxel in bulk and its pharmaceutical dosage form. An enable C18G, 250mm, X4.6mm i.d, 5µm particle size column was used with photo diode array UV-Visible detector. The mobile phase consisting of Acetonitrile and water in the ratio of 80:20V/V was used. The flow rate was 1ml/min and the effluent was monitored at 228nm. The retention time of the drug was 3.737 minutes. The method was linear over the concentration range of 30-250µg/ml. the method precision for the determination of assay was below 2% RSD. The percentage recovery of paclitaxel was 99.41 – 100.83%. The validation of method was carried out utilizing ICH guidelines. Keywords: Paclitaxel, RP- HPLC, Development, Validation.
Authors and Affiliations
*Sree Rama Murthy Pyla, Jogendra Kumar YVV, Jagadeesh Panda, Vara Prasad A, N. Sriram
Keywords
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