BLT Stages

In the pharmaceutical industry, it’s mandatory that a new compound or a new pharmaceutical formulation can be evaluated. For this reason an analytical method should be developed for quantitative and qualitative determination of the new compound. When the method has been developed, it’s required by guideline to validate it. The objective of validation of an analytical method is to demonstrate that the method is suitable for the intended use, meaning that the method will generate consistent and reliable results. The aim of this paper is to validate a UPLC method for the identification and assay determination of methylparaben (0,018mg/ml) and propylparaben (0,002mg/ml) in a microsuspension with Xanthan gum. The validation precedes some preparatory steps, namely a feasibility study and a pre-validation study. In a feasibility study the test method will be evaluated based on the information from the customer. When the results are comparable, the pre-validation is following up.  A pre-validation study has two functions namely to prevent for unexpected results during the validation and it helps with the pre-defining of the acceptation criteria for evaluation. 

The following validation characteristics will be tested during this method validation: system suitability, specificity, accuracy, precision, linearity, range, filtration study and stability of solutions.

It is demonstrated that the method is specific, accurate, linear and precise over the concentration range 60.0-140.0%. It can be concluded from these validation results that the method is suitable for the identification and determination of methylparaben and propylparaben in a microsuspension with Xanthan gum. Furthermore the reference and sample solutions are stable for at least 7 days and all the validated filters are suitable to perform the sample preparation.