The present work aims to develop and validate an analytical method for determining the assay of an antibacterial drug in a gel formulation. Analytical Method Validation is crucial to ensure that the method provides accurate and reproducible results in line with the requirements of various pharmacopoeias and guidelines. This study focuses on the development and validation of a sensitive and accurate Reverse Phase-High-Performance Liquid Chromatography (RP-HPLC) method.
The HPLC method was rigorously validated, demonstrating its suitability for intended use. Specificity tests confirmed that the method accurately identified and quantified the drug of interest, with no interference from diluents, placebos, or impurities. The system suitability results indicated precision and consistency, with a Relative Standard Deviation (RSD) of 0.33% for five replicate injections.
The method's precision was verified with RSD values of 0.33% for retention time and 0.46% for the area of the drug peak. Intermediate precision demonstrated similar results, with an RSD of 0.50% for assay values. Stability tests showed that the method maintained its accuracy over time, with the Besifloxacin peak area varying within ±2.0% from the initial linearity.
The linearity of the method was established with a correlation coefficient of 0.998 and a regression coefficient of 1.000, meeting the criteria of not less than 0.995. The method's accuracy was confirmed through mean % recovery values ranging from 98% to 101%, with an RSD of 1.2%, well within the acceptable range of not more than 2%.
In conclusion, the developed RP-HPLC method is robust, precise, and suitable for determining the assay of the antibacterial drug in a gel formulation. It complies with the relevant pharmacopoeial and regulatory guidelines, offering a reliable tool for quality control in pharmaceutical analysis. The results demonstrate the method's ability to maintain accuracy and precision, making it a valuable addition to analytical procedures in the pharmaceutical industry.
Keywords: Analytical method validation, Antibacterial, High performance liquid chromatography, Quantification, Topical gel
