Question

What are impurities and their testing method of metoclopramide ?

Answer 1

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.