Abstract

A HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF FORMALDEHYDE IN D-SERINE API

Rajendra Phadke*, Amit Gosar, Deepesh Patil, Kushal Gupta and Rupali Mali

ABSTRACT

This study was performed for determination of formaldehyde content in D-Serine API by high performance liquid chromatography (HPLC) method. Formaldehyde is a dangerous a toxic chemical and affecting the human health. In the manufacturing process of serine products most of time formaldehyde chemical was used, hence need to control this chemical with limit level. In the HPLC method D-Serine product was react with 2,4-dinitrophenylhydrazine (DNPH) as derivatizing agent in presence of acidic condition 1 N HCl to forms hydrazone derivatives. This reaction was performed under warmed condition at 40οC for 30min in water bath. The derivatized product was detected on photo diode array detection at wavelength 360 nm. This method was validated as per ICH guidelines and gives average recovery of formaldehyde at the three different levels 50, 100, and 150 ppm varied between 90% to 100%. The method is linear from the limit of quantification at 25 ppm to 1089 ppm levels. Hence method is intended for formaldehyde analyses in D-serine API sample with stable derivatization, minimum residue loss, excellent recovery, and accurate results with a sensitive limit of detection 86 ppm.

Keywords: Formaldehyde, HPLC, 2,4-dinitrophenylhydrazine (DNPH), D-Serine.