Tuesday , 16 April 2024

A Validated RP-HPLC method for Simultaneous Estimation of Gemcitabine and Clarithromycin in Bulk and Pharmaceutical Dosage form

Mulla Rafiyuddin*, Akepogu Jayaraju, J. Sreeramulu
Department of Chemistry, Sri Krishnadevaraya University, Anantapuramu–515003, Andhra Pradesh, India

A B S T R A C T
A reverse phase high performance liquid chromatographic method was developed for the determination of Gemcitabine and Clarithromycin in bulk and pharmaceutical dosage form. The separation was carried out on a [Column:  Agilent C18 (4.6 x 250mm, 5µ m, Make: Waters)] using a mobile phase mixture of Methanol, Sodium acetate buffer in a isocratic elution at a flow rate of1ml/min. The detection was made at 274 nm. The retention time of Gemcitabine and Clarithromycin was found to be 2.369 and 5.992 min respectively, Calibration curve was linear over the concentration range of 10μg-50μg and 120μg-300μg of Gemcitabine and Clarithromycin. The propose method was validated as per the ICH guidelines. The method was accurate, precise, specific and rapid found to be suitable for t he quantitative estimation of related substances in drug an d pharmaceutical dosage form.
Keywords: Gemcitabine and Clarithromycin, HPL C, Validation studies

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