Abstract :
A simple, sensitive, precise, selective reverse phase high performance liquid chromatographic method was developed and validated for erlotinib hydrochloride in tablet dosage form.(0.02M)The separation was achieved on C18 column (150mm×4.6mm.i.d.,5.0?m) using potassium dihydrogen phosphate: acetonitrile in the ratio 50:50v/v as mobile phase having pH 4.5 was adjusted with methanol and flow rate 1ml/min. Detection was carried out using a UV detector at 248nm. The column temperature was adjusted at 30?C. The method was validated for precision, linearity and range, stability and robustness. The developed and validated method was successfully applied for the quantitative analysis of ERLONAT tablets. The total chromatographic analysis time per sample was about 7min with Erlotinib eluting at 6.547min.Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curves were linear over the concentration ranges, 88.32- 132.48?g/ml for erlotinib. The high recovery confirms the suitability of the proposed method for the determination of Erlotinib in ERLONAT tablets. The results of analysis have been validated according to ICH guideline requirements. The method can be applied for Erlotinib hydrochloride tablets.
Keyword :
Erlotinib, RP-HPLC, Method validation, Tablets