Determination of Lapatinib in Bulk and Tablet Dosage Form using Ultraviolet Spectrophotometric and RP-HPLC Analytical Methods

Abstract

Objectives: The present article involved the development of sensitive and validated Ultraviolet (UV) Spectrophotometric and reverse phase liquid chromatographic and method for the determination of lapatinib in bulk and pharmaceutical dosage form. Materials and Methods: The present UV method is based on measurement of absorption at maximum at 268 nm using methanol as a solvent. In the High Performance Liquid Chromatography (HPLC) method, Waters HPLC with Empower-2 Software with PDA Detector was utilised. Acetonitrile and phosphate buffer in the ratio of 65:35 (v/v) utilised as a mobile phase. Results: In the UV Spectrophotometric method the drug obeyed beer lambert’s law in the concentration range of 2-20 μg/ml with regression coefficient 0.999. In HPLC method the linearity level was 20-200 μg/ml. The developed UV and HPLC methods have been successfully applied in the validation study. The percentage purity of the marketed dosage form of lapatinib was found 99.68 % and 99.82% for UV and HPLC method. In both methods, the percent RSD of all the validation parameters examined as recommended in the ICH guidelines was found to be less than 2. The highest degradation (19.58%) occurs in alkaline stressed environments in the force degradation analysis by HPLC technique. The degradation of lapatinib is also associated with remaining stressed conditions. Conclusion: The two methods developed were found to be accurate, simple and validated for estimating lapatinib in the form of bulk and tablet doses.