Validated Reverse Phase Stability-Indicating Hplc Method for Clofarabine in the Presence of Degradation Products and its Process-Related Impurities.
Journal Title: IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) - Year 2016, Vol 11, Issue 6
Abstract
The study reports simultaneous determination of clofarabine and its related substances of impurities in their pharmaceutical dosage form using validated stability indicating reverse phase high performance liquid chromatography method. The column used was Inertsil ODS 3V, 250x4.6 mm, 5 μm using phosphate buffer pH 3.0: acetonitrile with gradient mixing mobile phase at a flow rate of 1.0 ml/min. Quantification was achieved with UV detection at 250 nm over the concentration range 0.05-20 μg/ml and % recovery was found to be in the range of LOQ to 150 % for clofarabine and related impurities by the RP-HPLC method. The proposed method was validated with respect to precision, linearity, accuracy, selective, sensitive and robustness. The method was successfully applied for the estimation of clofarabine and its related compounds in injection dosage forms.
Authors and Affiliations
Jagadeswara Rao K, Murali Mohan SV, *Rama Rao Malla1
Keywords
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- EP ID EP386786
- DOI 10.9790/3008-1106036372
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