Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF GEMCITABINE AND CLARITHROMYCIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Y. Anil Kumar*, Y. Sirisha, A. L. Harini and A. Prathyusha

Abstract

A simple, accurate and precise Stability indicating RP-HPLC method for the estimation of in pure and pharmaceutical dosage form has been reported. Quantitative estimation of Gemcitabine and Clarithromycin was done by using WATERS HPLC 2965 SYSTEM with Auto Injector and PDA Detector on a Chromosil C18 Column (150mm x 4.6mm) 5μg.). A 10μL syringe was used for injecting the samples. Data was analyzed by using Empower 2 software. UV-VIS spectrophotometer shimadzu with special bandwidth of 2mm and 10mm and matched quartz was used for measuring absorbance for Gemcitabine and Clarithromycin solutions. The mobile phase consists of a water: phosphate Buffer: Methanol (35:65v/v) And at a flow rate of 1 milliliter/minute. Gemcitabine and Clarithromycin were eluted at approximately 7 minutes. The wavelength was found to be 254nm. A linear response was observed in the concentration ranges of 20- 60μg/ml with a regression coefficient of 0.999. Forced degradation studies were performed on pure sample of Gemcitabine and Clarithromycin using acid (0.1 Normal (N) hydrochloric acid), base (0.1 N sodium hydroxide), peroxide (30% H2O2) and thermal (105°C) conditions. The developed method was validated with respect to specificity, precision (% RSD about 0.4%), linearity (linearity of range about 20-60 μg/mL), robustness, LOD and LOQ values were found to be 0.001μg/ml, 0.005μg/ml and 0.004μg/ml 0.015μg/ml respectively.

Keywords: High performance liquid chromatography, Gemcitabine and Clarithromycin.