PROJECTS
HPLC Method Development and Validation
Analytical method validation ensures that various HPLC analytical techniques shall give reliable and repeatable results; it is a crucial step in developing new dosage forms as it provides information about accuracy, linearity, precision, detection, and quantitation limits.
According to the ICH guideline, “the objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose.” It is now obligatory in the process of drug development to supply the validation data for the responsible authorities. Guidelines for analysis method validation include ICH and USP guidelines
Dissolution Method Development and Validation
Dissolution is the process in which a substance forms a solution. Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. ... To properly evaluate the dissolution of drug products, it is critical for procedures to be standardized.
Formulation development
A formulation is the composition of a drug product that contains the active pharmaceutical ingredient (API) and other inactive ingredients.
Formulation design and development involves a combination of various components and optimization of process parameters. Excipients are considered as the vital component of the quality drug product, and it is mandatory to ensure that product development should not result in any incompatibility