Development and Validation of Stability Indicating HPTLC Method For Estimation of Gefitinib

Abstract

The development and validation for the estimation of Gefitinib (Rf) in volume of drug, a rapid, selective and stability indicating high performance thin layer chromatography (HPTLC) method was developed. Gefitinib was chromatographed on silica gel 60 F254 thin layer plate with Me-OH: CHCL3 (7:3 V/V) as the mobile phase and spectrodensitometric scanning-integration was performed at a 254nm via in a Camag TLC Scanner III and method was established toward provide dense spot of Gefitinib (Rf = 0.76±0.02). The polynomial deterioration records intended in favor of the calibration plot to show bettercorrelation regression was 0.964 within the conc. series between the 200-1200 ng/spot in support of Geftinib.The technique was validated during the linearity, accuracy, precision, repeatability and specificity. The LOD & LOQdesigned of the Gefitinib was originated toward 200& 1000ng/spot, correspondingly.Gefitinib was dishonored in the acidic, basic and oxidation situations which show, entire of the degradation creation was better resolute as of the API. Gefitinib drug was not degraded in thermal and photolightic degradation.The process was originated, and reproducible and discriminatory for the estimation of Gefitinib drug. The process could be effective to separate the drugs from their degradation products; it should be working in a stability indicating assay method.