Abstract
Author(s): Shirish Janardan Velankar, Ram Lokhande, Ravi Yadav, Ramchandra Pawar
A simple rugged and user-friendly and cost effective method to quantify formaldehyde and acetaldehyde in the drug substance, Rasagline by derivatizing it with 2, 4-Dinitrophenyl hydrazine (2, 4-DNPH) is presented using High Pressure Chromatography (HPLC). By employing HPLC-UV, the cost of analysis is reduced dramatically as compared to the traditional methods. Additionally, the use of 2, 4- DNPH ensures that all the probable carbonyl compounds in the drug substance, can be monitored using the same method. The separation were accomplished on an Ascentis Express C18 (100 mm x 4.6 mm x 2.7µ) using Water: Acetonitrile (70: 30 v/v) with a flow rate of 2.0 ml /min. The Method was validated for the analytical parameters viz., Specificity, Limit of Detection (LOD), Limit of Quantitation (LOQ), Linearity and Range, Precision – System, Method and Spiked and Accuracy. The limit of detection and quantitation was found to be 10 PPM and 30 PPM for formaldehyde w.r.t sample concentration 10 mg/ ml. The limit of detection and quantitation was found to be 20 PPM and 60 PPM for acetaldehyde w.r.t sample concentration 10 mg/ ml.
