The Case for User-Friendly Informatics Case study

PURPOSE

The Liquid Chromatography (LC) technology evolves constantly. The recent UPLC technology commonly provides better results than the older HPLC technology, especially finer detection combined with shorter time of analyses. However, despite its advantages, changing from HPLC to UPLC remains a challenge for many products and organizations. Our work underlines the key parameters to transfer more easily from an existing method to the new technology. Our approach is illustrated by the development of one UPLC method to replace two complex HPLC methods used to release two different compounds (A and B) of a drug product. (Figures 1A and 1B respectively).

F1a&b

METHODS

A first equivalency was quickly obtained with columns of similar selectivity and load (Figure 2).

f2

Changes in gradient times, flow rate and injection volume were rapidly done; taking into account lengths, diameters and volume of the HPLC and UPLC columns (Figures 3A and 3B).

F3a&b

The most rapid way is to work in matrix to determine the inter-influence of the column chemistry, the mobile phase composition and its pH on the chromatographic profile (Table 1).

T1

However, the influence of these chromatographic parameters can be checked individually too (Figures 4, 5 and 6 respectively).

Gradient was evaluated to improve the separation and selectivity of sample compounds (Figure 7).

f4 f5 f6 f7

A PDA detector and reference standards were used to enable quick identification and tracking of the peaks that are closely eluting, co-eluting or where elution order has changed (Figure 8).

f8

RESULT

Following a simple procedure, we successfully developed a new UPLC method (Figure 9) from two existing HPLC methods (Figure 1A and 1B) to combine the release of different compounds of a drug product.

This single method allows better efficiency than two complex HPLC methods, reducing both the run time by more than 50% (from 30+25 minutes to 25 minutes), the solvents consumption by almost 90% (from 97.5 mL to 10 mL) and the executional problems on the systems. Moreover, this new UPLC method allows analysis of 7 additional related compounds.

f9

CONCLUSIONS

From two challenging HPLC methods used for the release of different substances, a robust UPLC method has been developed following a simple process. The many advantages of the new UPLC method allow a reduction of the time of analysis to 50% and major cost savings of about $3000 per product analysis.

ACKNOWLEDGMENT

We thank Edwin Hoppenbrouwers and Kay Schmidt for their advices. This work was supported by Catalent Pharma Solutions.

http://www.catalent.com/index.php

 



Related Topics and Keywords

, , , , ,

Subscribe to our FREE newsletter

We will not sell or give your information to a third party. See our Privacy Policy