The Analytical Method Development for Genotoxic Impurities of Lapatinib Ditosylate Monohydrate by Reversed Phase
Siddharth Shah1, Vaibhavi Savalia1, Hitesh Vekariya1
1School of Pharmacy, RK University, Rajkot-Bhavnagar highway, Gujarat-360020, Rajkot, India.
Abstract:
An accurate, sensitive, and rapid reverse phase high-performance liquid chromatography method has been developed and validated for genotoxic impurities of Lapatinib ditosylate monohydrate. The present experiment utilizes the simple RP-HPLC technique. HPLC analysis was performed on a suitable column C-18. Column temperature maintained at 45°C. Chromatographic separation was achieved with mobile phase gradient program. The method suitability was validated according to the ICH guidelines Q2 (R2) for specificity, linearity, accuracy, precision, limit of quantification, limit of detection, and solution stability. Limit of detection of each impurity was found below 0.02 ppm, indicating that the developed method is highly sensitive without the use of any hyphenated technique. The calibration curve of each impurity was found to be linear within the concentration range of about 0.12 to 0.60 μg/mL. The regression data for calibration curve show good linear relationship. Correlation coefficient (r2) of each impurity was found above 0.99. The recovery of each impurity was found to be between 80% and 120%. The experiment results are given in detail in this research article.
