Simple, rapid, sensitive, accurate, robust & rugged stability indicating analytical method for determination of Erlotinib in pharmaceutical formulations is developed and validated by using UPLC & applied the developed and validated method for determining the assay of Erlotinib in tablets (Tarceva), as there is no official monograph & no analytical method by UPLC. Chromatography was performed with mobile phase containing potassium dihydrogen ortho phosphate, added 1mL of triethylamine and adjusted to pH 2.4 with orthophosphoric acid , with a flow rate of 0.3mL/min, C-18 column & UV detection at 225nm.The method was validated for linearity, accuracy, ruggedness, robustness, precision & bench top stability of sample & standard solution. Erlotinib tablets were subjected to different stress conditions like acid, alkali, peroxide, thermal, water & UV studies and checked for its specificity, degradation & stability. The developed method was very rapid with a run time of 3 min, accurate, robust, rugged and stable.
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