Volume : 12, Issue : 08, August- 2025
Title:
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF DRONEDARONE IN PURE FORM AND MARKETED PHARMACEUTICAL DOSAGE FORMS
Authors :
B.Raj Kumar*, Akhila.G, Navya.K, Akshitha.K, Vaishnavi.K, Jagadeesh.P
Abstract :
A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Dronedarone in bulk form and marketed formulation. Separation of Dronedarone was successfully achieved on a Phenomenex Luna ODS HG-5 RP C18, 5µm, 15cmx4.6mm i.d. column in an isocratic mode of separation utilizing Methanol : Phosphate buffer (0.01M, pH-3.2) in the ratio of 30:70% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 255nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 12-28mcg/mL for Dronedarone. The correlation coefficient was found to be 0.9995 for Dronedarone. The LOD and LOQ for Dronedarone were found to be 5.004µg/mL and 15.164µg/mL respectively. The proposed method was found to be good percentage recovery for Dronedarone, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.
Keywords: Dronedarone, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.
Cite This Article:
Please cite this article in press B.Raj Kumar et al., Development And Validation Of Rp-Hplc Method For Estimation Of Dronedarone In Pure Form And Marketed Pharmaceutical Dosage Forms., Indo Am. J. P. Sci, 2025; 12(08).
Number of Downloads : 10
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