Analytical Method Validation: The Importance for Pharmaceutical Analysis

of Pharmaceutical Analysis Review on Analytical Method Development and Validation

Analytical methods development must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for quality control release, testing of stability samples, testing of reference materials and to provide data to support specifications.Analytical method followed by process of establishing evidence that provides a high deg...

Analytical Method Development and Validation for Piracetam in Pharmaceutical Formulation

A simple, rapid and validated HPLC method was developed for determination of Piracetam in film coated tablets. A Lichrosorb® (RP-18 column with a mobile phase consisting of acetonitrile – phosphate buffer (5:95v/v)) was used. Quantitative evaluation was performed at 205 nm. The HPLC method is selective, precise and accurate and can be used for routine analysis of preparations in pharmaceutical ...

Analytical Method Validation for Biopharmaceuticals

Challenges in the analytical method development and validation for an unstable active pharmaceutical ingredient.

A sensitive high-performance liquid chromatography (HPLC) impurity profile method for the antibiotic ertapenem is developed and subsequently validated. The method utilizes an Inertsil phenyl column at ambient temperature, gradient elution with aqueous sodium phosphate buffer at pH 8, and acetonitrile as the mobile phase. The linearity, method precision, method ruggedness, limit of quantitation,...

Analytical Method Validation

In pharmaceutical industries, the validation of analytical methods is used to demonstrate that the method is fitted for its purpose; it must follow a plan which includes scope, performance characteristics, and acceptance limits. Analytical methods need to be validated or revalidated prior to their introduction into routine analyses (release of batch). The overarching philosophy in current good ...