(RP- HPLC) Method Development and Validation of Osimertinib in Tablet Dosage Form

Abstract

Osimertinib is widely used for the treatment of melanoma which is type of skin cancer hence, it is essential to develop simple, rapid, sensitive and specific RP-HPLC method for the determination of Osimertinib in tablet dosage form. Osimertinib samples were eluted in isocratic mode by using Supelco (acentis express) C18 column (25cm × 4.6 mm&5 μ) using filtered and degassed mixture of methanol: perchlorate buffer (20:80) %v/v as mobile phase at 45°C with a flow rate of 1ml/min. and injection volume of 20µl and the detection was estimated at 270 nm with the help of UV-VIS detector.The retention time for Osimertinib was observed at 3.28 minutes. The method was linear over the range of 10 to 80 µg/ml with linear regression coefficient (r²) 0.9994. The RP- HPLC method was validated as per ICH guidelines. The develop method was validated with respect to system suitability, specificity, linearity, precision, accuracy, and robustness. The method was accurate, linear, precise, specific, selective, and rapid suitable for the quantitative estimation of Osimertinib in tablet dosage form. So, the proposed method can be applied for routine analysis of Osimertinib in tablet dosage form.