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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 11
First page : ( 5407) Last page : ( 5412)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.00938.7

Validated Analytical Method for the Estimation of Gemcitabine from its Pharmaceutical Formulation by RP-HPLC

Mishra Survi, Narenderan S. T., Babu B.*, Mukherjee Kuntal, Meyyanathan S. N.

Department of Pharmaceutical Analysis, JSS College of Pharmacy, Udhagamandalam, Tamil Nadu, JSS Academy of Higher Education & Research, India

*Corresponding Author E-mail: babu@jssuni.edu.in

Online published on 9 April, 2020.

Abstract

A simple, sensitive and rapid high performance liquid chromatographic method has been developed for the determination of Gemcitabine. Chromatographic separation was achieved on an Inertsil ODS-3V column (250mm x 4.6mm; 5μm) with a mobile phase consisting of water: acetonitrile (90: 10; pH 3.5 adjusted with orthophosphoric acid) with a flow rate of 1.0ml/min (UV detection at 270nm). Linearity was observed over the concentration range of 1–120μg/ml with a regression equation y=19773x+ 86063 and having a regression value (R2)= 0.998. The limit of detection (LOD) and limit of quantification (LOQ) values found to be 10ng/ml and 20ng/ml, respectively. The percentage recovery of the marketed formulation was found to be 100.08%. Validation revealed that the preferred method was specific, accurate, precise, reliable, robust, reproducible and suitable for the quantitative analysis.

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Keywords

Gemcitabine, RP-HPLC, Validation, LOD, LOQ, Robustness.

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