RP-HPLC Method Development and Validation for the Estimation of Fidaxomicin from Bulk and Tablet Dosage Form

Abstract

Background: Fidaxomicin is a vital antibiotic for pharmaceutical formulations and its precise estimation in bulk and dosage forms is crucial for quality control and regulatory purposes. A validated analytical method is used to generate trustworthy data for fidaxomicin determination.

Objective: The purpose of this study was to develop and validate a reverse-phase high-performance liquid chromatography (RP-HPLC) method for the determination of fidaxomicin in bulk and pharmaceutical dosage form with respect to accuracy, precision, and robustness in based on ICH guidelines.

Method: The method was undertaken on a Symmetry C18 Inertsil ODS-3V column (4.6x250mm, 5µm). The mobile phase consisted of 0.1% ortho-phosphoric acid (OPA) and acetonitrile (05:95), with a flow rate of 1.0 mL/min. Detection was performed with a UV detector at 228 nm. The proposed method was validated as per ICH guidelines.

Result: The validation parameters are met by Specificity, linearity, precision, accuracy, robustness, and system suitability. The retention time for fidaxomicin was 6.5 minutes, and the technique showed linearity within a concentration range of 10 to 150 μg/mL. This method’s limits of detection (LOD) and quantification (LOQ) were set at 6.67 μg/mL and 20.22 μg/mL, respectively.

Conclusion: Fidaxomicin determined in bulk and pharmaceutical dosage forms using the established RP-HPLC technique, which is robust, specific, linear, precise, and accurate. This validated method can be reliably used for routine quality control analysis and regulatory compliance in pharmaceutical industries.