Development and validation of an analytical methodology using high performance liquid chromatography for the determination of betamethasone and chlorphenamine maleate in an oral solution

Abstract

The present work consisted in the development and validation of an analytical methodology for the determination and quantification of chlorphenamine maleate and betamethasone in an oral solution. The main objective of the development of a new analytical methodology for this product was to create a procedure that allows analysis of both active principles simultaneously in order to optimize the time and costs involved, considering that they are routinely analysed separately. The following parameters were evaluated: robustness, linearity, accuracy, precision, selectivity, limit of detection and quantification, and rank. The treatment of the sample was performed according to established protocols for the pharmaceutical industry.The results obtained were as follows: for the active substance betamethasone, the calibration was adjusted to a linear regression model in a concentration range of 1.359 to 2.576 ug mL-1 with coefficients of determination (R2) between 0.993 and 0.998. For chlorphenamine maleate, the calibration was adjusted to a linear regression model in a concentration range of 11.053 to 20.606 ug mL-1 with determination coefficients (R2) between 0.994 and 0.998.Considering the results obtained from validation, this analytical methodology provides reliable, accurate, robust and accurate analyses in linearity, precision, selectivity, limits of quantification and detection, and range for the determination of both active ingredients in an oral solution.