Studies in Stability Indicating Chromatographic Method Development and Validation

Abstract

Rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Brivaracetam in its pure form as well as in tablet dosage form. Chromatography was carried out on Inertsil ODS-3, 250 mm x 4.6 mm, 5μm column using a mixture of phosphate buffer: acetonitrile (60:40%v/v) as the mobile phase at a flow rate of 1.0 ml/min, the detection was carried out at 205 nm. The retention time of the brivaracetam was 3.267 min. The method produces linear responses in the concentration range of 100-300 μg/ml of brivaracetam. The method precision for the determination of assay was below 2.0 %RSD. The method was found to be sensitive, accurate and precise useful in the quality control of bulk and pharmaceutical formulations.
Introduction: Analysis is necessary for all goods and services, but it is especially important for medications because they deal with human life. Analytical chemistry is the study of chemical additives' separation, measurement, and identification. Analytical knowledge is divided into two kinds.

Objectives: To develop UV and HPLC method for determination of Brivaracetam in the Pharmaceutical Dosage form ,To study stability indicating method of drug

Methods: Understanding the Physicochemical properties of drug molecule. ➢ Selection of chromatographic conditions.➢ Developing the approach of analysis. ➢ Sample preparation ➢ Method optimization➢ Method validation.

Results: HPLC method development and validation involves a systematic approach to designing and verifying an analytical method for separation, detection, and quantification of analytes. The process typically includes understanding the sample's characteristics, selecting appropriate chromatographic conditions, optimizing the method, and then validating the method's performance.

Conclusions: A simple, rapid, selective, precise and accurate HPLC method has been developed for the estimation of Brivaracetam in bulk drugs and its Tablet dosage forms.The test method is validated for Specificity (Selectivity), Linearity (Range), Precision (System, Method), Accuracy (Recovery), Stability of analytical solution  and Filter suitability found to be within the specified limit.