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What are impurities and their testing method of metoclopramide ?
Impurities are chemical substances inside a confined amount of liquid, gas, or solid, which differ from the chemical composition of the material or compound.
The role of impurity analysis is dynamic and conducted
throughout the pharmaceutical drug development process. Impurity
based activities throughout the development of therapeutics are
uniquely focused in terms of their application needs as the drug
product progresses downstream to commercialization. Central to the
discovery and ongoing monitoring of impurities is liquid
chromatography and mass spectrometry coupled with
appropriate informatics solutions. Waters’ portfolio provides the
most comprehensive of liquid chromatographic techniques, mass
spectrometry, data management, and column chemistries to address
your challenges.
The Agilent 1290 Infinity LC system was applied for the
determination of impurities in a metoclopramide hydrochloride
formulation. The system was equipped with a high pressure pump
capable of delivering up to 1200
bar and a new fast and sensitive diode array detector (DAD). Method
development consisted of the translation of conditions from a
conventional instrument (Agilent 1200 Series LC system) equipped
with a column packed with 3.5-µm particles to an UHPLC system
(Agilent 1290 Infinity LC system) equipped with columns packed with
1.7-µm particles. The data from the two
systems were compared and evaluated in terms of accuracy,
precision, and repeatability.