Analytical Method Development and Validation of Bendamustine in Bulk Using RP-HPLC
Journal Title: Open Access Journal of Pharmaceutical Research - Year 2018, Vol 2, Issue 2
Abstract
A simple, sensitive, precise, accurate and economical method was developed and validated for the estimation of Bendamustine in bulk or formulation by RP-HPLC method using Inertsil column ODS of dimensions ODS -2, (150 x 4.6) mm, 5 µm. The mobile phase (trifluoroacetic acid and acetonitrile ) was pumped at a flow rate of 1.5ml/min in the ratio of 68:32 and the eluents were monitored at 230 nm. Linearity was obtained in the concentration range of 10%-150% with R2 0.999. LOD and LOQ were found to be 2.9 µg/ml and 8.75 µg/ml. The method was statistically validated according to ICH guidelines. RSD was found to be less than 2% indicating high degree of accuracy and precision of the proposed HPLC method. The percentage recovery was in good agreement with the labeled amount in the pharmaceutical formulations.
Authors and Affiliations
Bhawani S*, Nageshwari HG, Mamatha G, Venu M, Sai Krishna M and Murali Krishna KS
Keywords
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- EP ID EP745917
- DOI 10.23880/oajpr-16000158
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