Analytical Method Development And Validation For The Simultaneous Estimation Of Phosphate And Dextrose Content By Rp-Hplc In Cabazitaxel Injection.

Abstract

A simple, accurate, precise, rugged, robust, linear and reproducible method was developed by RP-HPLC method for simultaneous estimation of phosphate and dextrose content which was used in the formulation of Cabaxitaxel injection dosages form. An isocratic and simple RP-HPLC method was developed and validated on column Rezex HPX-87H (300 x 7.8) mm. 0.005 M H2SO4 was used as mobile phase. The flow rate was adjusted to 0.6 ml/min, column oven temperature 40°C and the detector cell temperature was adjusted 45°C by using refractive index detector. The retention time for both content (phosphate and dextrose) was kept 40 minutes. Retention time of phosphate was found about 11 minutes while dextrose was at 14 minutes. Correlation coefficient of phosphate was 0.9999 while for dextrose content was found 0.9999 from 5ppm to 800ppm. Robustness was performed by deliberate changes in chromatographic conditions, method was found robust and usable even during small variations encountered in routine analysis and stability study. Stability of phosphate and dextrose content was performed at 5°C upto 1 day and found stable. Proposed method was validated for specificity, accuracy, precision, linearity, range, ruggedness & robustness. This developed method can be applicable for routine and stability quantitative analysis. Keywords: Cabaxitaxel, Phosphate and Dextrose, RP- HPLC, Method Development and Validation