A Novel HPLC Method for Identification and Quantification of Ramucirumab in Tablet Dosage Form

A novel approach has used for the develop and validate a rapid, accurate, simple, reproducible and an isocratic RP-HPLC method with PDA detector for the estimation of Ramucirumab drug in pharmaceutical dosage forms. Ramucirumab was separated using YMC C18 4.6 X 150 mm, 5 μm analytical column, a Waters HPLC (USA) and a mobile phase consists of methanol and water in the ratio of 80: 20% v/v, delivered at 0.6 ml/min with 20 μl injection volume. The column was maintained at ambient temperature, and the detector was set at wavelength of 320 nm. The system suitability parameter for Ramucirumab such as theoretical plates and tailing factors were found to be 4159 and 1.5 respectively. Linearity was established for Ramucirumab in the range of 20–100 ppm concentration levels with correlation coefficients (r²) of 0.999. The intra and inter-day precision % RSD values were found to be 0.24 and 0.39 respectively. The limit of detection (LOD) and limit of quantification (LOQ) value were found to be 0.32 and 0.98 μg/ml respectively. The method was validated for all of the above parameters according to International Conference on Harmonization (ICH) guidelines. This method can be used for the estimation and analysis of Ramucirumab drug in Active Pharmaceutical Ingredients and Pharmaceuticals.