Everolimus is semisynthetic derivative of sirolimus, which is isolated from Streptomyces hygroscopicus. A novel reversed phase high performnce liquid chromatography (HPLC) method for determination of the everolimus in the presence of degradation product or pharmaceutical excipients. Seperation was carried out using Cosmosil C18 (250mm x 4. 6ID), column having particle size 5 micron using acetonitrile and methanol mixture, and pH adjusted to 3, a flow rate of 1. 0 mL/min, and ultraviolet detection at 285nm. A retention time nearly 3. 806 min was observed. The calibration curve for everolimus was linear from range of 5 -25 µg/mL with limit of detection and limit of quantitation of 0. 0817 & 0. 2478 µg/mL, respectively. Analytical validation parameters such as selectivity, specificity, linearity, accuracy and precision were evaluated and relative standard deviation value for all the key parameters were less than 2. 0%. The stability-indicating method was developed by exposing the drug to stress conditions of acid and base hydrolysis, oxidation, photodegradation, and thermal degradation; the obtained degraded products were successfully seperated from the APIs. This method was validated in acceptance with ICH guidelines and results within the acceptance criteria.
Everolimus, reversed-phase high performance liquid chromatography, stablity, validation
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