A RP HPLC- PDA Method Development and Validation of Amoxicillin, Vonoprazan Clarithromycin in Bulk and Pharmaceutical Dosage Forms - A Stability Study

The objective of the project is to establish a dependable RP-HPLC-PDA method for the concurrent quantification of Amoxicillin, Vonoprazan, and Clarithromycin in bulk and mixed formulations.An efficient, cost-effective, and dependable method for quantifying Amoxicillin, Vonoprazan, and Clarithromycin has been established utilizing the RP-HPLC technique.To effectively isolate Amoxicillin, Vonoprazan, and Clarithromycin, 1.0 l of a 100% solution was injected into a Luna phenyl hexyl column (250 x 4.6 mm, 5 m).The mobile phase comprised 0.1% TFA: The solvent composition consisted of methanol and acetonitrile in a ratio of 60:20:20, with a flow rate maintained at 1 ml/min and a detection wavelength established at 231 nm.The column and the injection port were maintained at a constant temperature of 30 C throughout.The retention times (RT) of Amoxicillin, Vonoprazan, and Clarithromycin were recorded at 2.54 min, 4.20 min, and 5.72 min, respectively, in accordance with established system appropriateness criteria.Linear responses were noted for Amoxicillin, Vonoprazan, and Clarithromycin within the ranges of 125 to 750 g/ml, 5 to 30 g/ml, and 125 to 750 g/ml, respectively.The LOD and LOQ values were determined as 0.5 g/ml and 2 g/ml for Amoxicillin, 0.018 g/ml and 0.02 g/ml for Vonoprazan, and 0.5 g/ml and 2 g/ml for Clarithromycin.The % RSD values for both precisions were evaluated within the range of 0.4 to 0.8.The average recovery of Amoxicillin, Vonoprazan, and Clarithromycin ranged from 99.9% to 100.9%.The statistical analysis of the validation parameters verified that the approach was dependable for its accuracy, sensitivity, and precision, while also demonstrating a significant level of sensitivity.The examination of analytes under diverse stressful conditions ensures the stability of the substances, hence confirming their representation of the method's stability indication.The newly developed technique is highly effective in isolating Amoxicillin, Vonoprazan, and Clarithromycin from each other.The degradation products generated under stress conditions were also isolated with high resolution.The research determined that the proposed strategy has significant implementation in the pharmaceutical industry.