Stability Indicating RP-HPLC Method for the Estimation of Everolimus in Pharmaceutical Formulations

The present study was undertaken to develop a validated stability-indicating liquid chromatography method for estimating Everolimus in commercial tablet dosage forms. Chromatographic separation was achieved on Kromasil C18column(100mm x 4.6 mm, 5m) with mobile phase containing potassium dihydrogen orthophosphate buffer and acetonitrile taken in the ratio 75:25 v/v. The pH was adjusted to 3.0 with dilute orthophosphoric acid at a flow rate of 1.0 mL/min and the eluent was monitored at 270 nm. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, precision, linearity, accuracy and robustness. Linearity range was found to be between 5-30 ppm and the linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating that the accuracy and precision of the method are good. Statistical analysis proved that the method was precise, reproducible, selective, specific, and accurate for analysis of Everolimus. All the degradation products formed during forced degradation studies were well separated from the analyte  peak.