Importance of HPLC in Cleaning Validation of Laboratory Glassware
HPLC has
made significant contributions in detection and quantitative estimation of
organic compounds.
In pharmaceutical analysis HPLC has been extensively used in
assay of the active ingredient as well as related impurities which are present
in formulations in very low concentrations.
Estimation of related substances
was not possible using other conventional analysis techniques.
This unique
ability of HPLC has been successfully exploited for validation of glassware
cleaning before it can be put to use for making sensitive analytical
determinations.
It is clear
that glassware should be cleaned to complete satisfaction so that you are
confident of the results communicated by you.
In case you lack confidence then
you should be prepared for criticisms on your reports.
Next the
question will arise if you can rely on adequacy of your cleaning or further
cleaning would be necessary. In other words cleaned glassware will require
validation for cleanliness before use.
Cleaning validation is a set of
practices laid down to ensure the effectiveness and consistency of the cleaning
method for removal of residues from earlier analysis, contaminants or even from
the detergents used for cleaning.
US FDA prescribed screening requirements
under GMP through the standard 21 CFR 211.67 covering manufacture and testing
of drugs. Click
here to See the link.
Laboratory
glassware cleaning involves repetitive rinses with deionised water or an
organic solvent followed by drying in hot air oven.
It is important to use
water or solvent of high purity grade so that it does not contribute to the
contamination of the glassware. During analysis using sophisticated analytical
techniques such as HPLC you can come across a set of peaks (referred to as
ghost peaks) whose presence cannot be explained.
The first thing that can come
to your mind could be that such peaks result from impurities present in
available standards, blank solutions, reagents or even unclean samples. Such
sources of contamination can be investigated independently but due
consideration should be given to inadequate cleaning of the glassware before putting
it to use.
The residues
remaining after cleaning and levels of detergents used in the cleaning process
or trace impurities present in de-ionized water or organic solvents
necessitates use of a sensitive analytical technique.
HPLC is a good choice as
it offers a large number of possibilities due to selection from a range of
columns and detectors. Generally HPLC systems with a UV detector, photodiode
array detector and a C-18 column in reverse phase mode is adequate for the
purpose. HPLC offers high sensitivity and detection limits besides providing
advanced automation features that can contribute to large scale studies on
cleanliness validation of volumetric glassware items as per requirements
mandated by the standard
Lab-Training
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