Development and Validation of a Rapid RP-HPLC Method for the Determination of Pemetrexed in Lyophilized Powder for Injection

Louis Kwame Dotse and Carlos Martin Infante Cordova*

An economic, rapid and versatile RP-HPLC method for the determination of pemetrexed, an effective antifolate in lyophilized powder for endovascular injection, was developed employing a Luna C18 Column (250 × 4.6 mm; 5 μm), and spectrophotometric detection (analytical wavelength at 254 nm). A column oven temperature of 25°C and a mobile phase composed of ACN: Sodium dihydrogen orthophosphate buffer of ratio 30 v/v:70 v/v with pH adjusted to 4. The flow rate was 0.8 ml/min in isocratic elution with a 10:1 of injection volume of sample. The method validation was performed in accord with the ICH guidelines, considering parameters as accuracy, precision, linearity, robustness, limits of detection and quantification. The linear dynamic range was between 80 μg/ml and 120 μg/ml with a correlation coefficient of 0.999 and a runtime of 10 minutes. This propose method stable after 10 hrs. At 25°C proving to be reliable a such it can be used in the determination of Pemetrexede in Pharmaceutical formulation for injectable.

Published Date: 2023-09-01; Received Date: 2023-08-02