Method Equivalency for The Analysis of Paracetamol

Agilent Technologies has produced an application note describing a method to achieve seamless method transfer for the analysis of paracetamol and its impurities and signficantly decrease analysis time.

Introduction
Instrument-to-instrument method transfer is an important topic for laboratories throughout different industries. Especially for validated methods in the pharmaceutical industry, instrument‑to-instrument method transfer is compulsory, but it is also important in QA/QC in other industries. One example of instrument-to-instrument method transfer is method transfer to newer LC instruments, such as the Agilent 1260 Infinity II LC. This application note shows the analysis of paracetamol and its impurities using an Agilent 1260 Infinity LC, and the seamless method transfer to a 1260 Infinity II LC. In addition, decreasing the analysis time by making full use of the pressure range of the 1260 Infinity II LC will be shown.

The analysis of impurities in drugs is critical in the pharmaceutical industry. According to ICH guideline Q3A (R2), impurities at or above 0.05 % in new drug substances need to be reported, and impurities at or above 0.1 % in new drug substances need to be identified.

Results and Discussion
This application note shows the analysis of paracetamol and its impurities on a 1260 Infinity LC using the chromatographic conditions described within. The method for analysis of paracetamol and its impurities was transferred for proof of equivalency and without any changes to the 1260 Infinity II LC. In terms of area precision, the 1260 Infinity II LC outperforms the 1260 Infinity LC.

Conclusions
Method transfer for the analysis of paracetamol and its impurities from the Agilent 1260 Infinity LC to the Agilent 1260 Infinity II LC showed a maximum retention time deviation of less than 1 % while achieving the same peak resolution. This proves the equivalency of the 1260 Infinity II LC compared to the 1260 Infinity LC for the analysis of paracetamol and its impurities, and shows the possibility of seamless method transfer.