New spectrophotometric techniques for the estimation of osimertinib mesylate in tablet dosage form

Abstract

Osimertinib Mesylate is used for a treatment of non small cell lung cancer (NSCLC). Whereas only few simple, precise and accurate spectrophotometric methods were developed for the determination of Osimertinib Mesylate (tagrisso) in pharmaceutical dosage forms. The absorption maxima was found to be at 267 nm in method A (0.1N HCl) and shows linearity over the concentration range of 0.002-0.02 µg/mL with regression equation y=0.4323x + 0.0104 (r² = 0.9992). In Method B (Sodium acetate buffer, pH 4.5) the drug obeys Beer Lambert’s law (λ_max267nm) in the concentration range of 0.002-0.02 µg/mL with regression equation y=0.484x-0.017(r²= 0.9992). In Method C (phosphate  buffer, pH 7.2) the drug obeys Beer Lambert’s law (λ_max267nm) in the concentration range of 0.002-0.02 µg/mL with regression equation y=0.2949x+0.0108(r²= 0.9992) In Method D (Methanol ) the drug obeys Beer Lambert’s law (λ_max267nm) in the concentration range of 0.002-0.02 µg/mL with regression equation y=0.6323x+0.003 (r²= 0.999). 1^st derivative spectrophotometric method (E, F, G and H) were developed in 0.1NHCl and Sodium acetate pH 4.5 and phosphate buffer pH 7.2 and methanol in which Osimertinib Mesylate obeys Beer Lambert’s law 0.002-0.02 µg/mL and 0.002-0.02 µg/mL and 0.002-0.02 µg/mL and 0.002-0.02 µg/mL with regression equations y=0.0259x + 0.0008 and y=0.0137x - 0.0005 and y=0.0097x-0.0008 and y=0.0087-0.0007 respectively. The proposed spectrophotometric method was validated as per the ICH guidelines and can be applied for the determination of Osimertinib Mesylate in pharmaceutical formulations. Osimertinib Mesylate, Derivative spectroscopy, Spectrophometry, Validation, Tagrisso.

Keywords: Tagrisso, Osimertinib Mesylate, Derivative spectroscopy, Spectrophometry, Validation.