1Department of Pharmaceutical Chemistry, Sree Chaitanya Institute of Pharmaceutical Sciences, LMD.Colony, Karimnagar-505527. AP
2Department of Pharmaceutical Chemistry, Sultan-Ul-Uloom College of Pharmacy, Mount Pleasant, Road# 3, Banjara Hills, Hyderabad-500 034
3University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, AP
*Corresponding Author E-mail: rajshaz@gmail.com
A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of Gefitinib in tablet dosage form. An Hypersil BDS RP C18, 250x4.6 mm, 5 μm partical size, with mobile phase consisting of 0.02 M Dipotassium Hydrogen ortho phosphate and Methanol in the ratio of 10:90 v/v was used. The flow rate was 1.0 ml/min and the effluents were monitored at 246 nm. The retention time was 3.7 min. The detector response was linear in the concentration of 25–300μg/ml. The respective linear regression equation being Y= 94342.26x+77672.7. The limit of detection and limit of quantification was 0.125μg/ml and 0.15μg/ml respectively. The percentage assay of Gefitinib was 99.5%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Gefitinib in bulk drug and in its pharmaceutical dosage form.
Gefitinib, RP-HPLC, Estimation, and Tablets
