Research Article

A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients

Table 4

Comparison between the methods used to determine formaldehyde in excipients or drug substances.

Analytical techniqueDerivatization and/or extraction times (min)Run time (min)Approx. recovery (%)Approx. precisiona (%)Approx. LODb (ppm)Ref.

GC-FID5>7No dataNo data7[21]
GC-MS2401586–993.70.02[19]
SHS-GC-FID30585–97≤30.05[20]
SHS-GC-MS2028No data3.10.05[20]
SPME-HS-GC-MSc6022.5106.5–113.53.13–13.19No data[18]
HPLC-UVNo data≥3584–970.5–1.20.5[22]
HPLC-UV6030No dataNo data0.03[15]
HPLC-UVNo dataNo data94.9–102.9No data10[23]
Proposed method15 or 251187.8–104.30.75–3.62.44

aIncluding inter- and intraday precision; bLOD in sample; cSPME: solid-phase microextraction.