Method development and validation of formaldehyde and acetaldehyde traces in TLHB bags used for API and food packaging

A simple rugged and user-friendly and cost-effective method to quantify formaldehyde and acetaldehyde in TLHB packaging sample extract and by derivatizing it with 2,4-dinitrophenyl hydrazine (2,4-DNPH) is presented using high pressure liquid 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 TLHB packaging can be monitored using the same method. The separation was achieved with Ascentis Express C18 (100 mm × 4.6 mm × 2.7 μ) 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 LOD and quantitation was found to be 10 ppm and 30 ppm for formaldehyde w.r.t sample concentration 10 mg/ml. The LOD and quantitation was found to be 20 ppm and 60 ppm for acetaldehyde w.r.t. sample concentration 10 mg/ml.