Simultaneous determination of paracetamol, 4-Aminophenol, 4-Chloroacetanilid, Benzyl alcohol,Benzaldehyde and EDTA by HPLC methodin paracetamol injection ampoule

Document Type : Original Article


1 Physic chemical Lab of AFA Chemi Pharmaceutical Co., Tehran, Iran

2 Institute of Nuclear Science and Technology, Tehran, Iran

3 Institute of Standard and Industrial Research of Iran (ISIRI), Tehran-Iran

4 Dept. of Pharmaceutics, Islamic Azad University, Pharmaceutical sciences Branch, Tehran, Iran


Paracetamol that is known as acetaminophen have the most consume as an analgesic and antipyretic
drug in the world. That is formulated in single compound or mixture at many forms such as
tablets, syrups, suspensions and drops. The last form is intravenous injections. Paracetamol derived
from 4-minophenol which is synthesized by acylated the P-acetaminophenol and acetic anhydride.
4-aminophenol is the main impurity at manufacturing of paracetamol which could produce by
hydrolysis during storage or synthesis under normal conditions (temperature, pH, etc.). Also,
4-chloroacetanilid may be observed as an impurity in the raw material of paracetamol synthesis.
Benzyl alcohol is a preservative that used in Paracetamol for injection. It will be very important if
there are analytical techniques to measuring paracetamol and its degradation products accurately and
easily. Undoubtedly the most important and widely used, separation technique is chromatography.
There are several reports about separation and quantitative determination of paracetamol lonely or
simultaneous determination of paracetamol and 4-aminophenol. In this paper investigated simultaneous
determination of paracetamol, 4-aminophenol, 4-chloroacetanilid, benzyl alcohol, benzaldehyde,
and EDTA in paracetamol for injection ampoules by high performance liquid chromatography. By
changing the ratio of mixing methanol and acetonitrile as mobile phase at the wavelength of 215 nm
and pH=3 separation of all compounds were completely done.