Volume : 13, Issue : 05, May – 2026
Title:
A NEW ANALYTICAL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ANALYSIS OF ACENOCOUMAROL (NICOUMALONE) IN API FORM AND MARKETED PHARMACEUTICAL DOSAGE FORMS
Authors :
Sunitha*, G. Deepika, Vijaya Kuchana, Pasupuleti Sunitha, G. Kalyani
Abstract :
A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Nicoumalone in bulk form and marketed formulation. Separation of Nicoumalone was successfully achieved on a Develosil ODS HG-5 RP C18, 5µm, 15cmx4.6mm i.d. column in an isocratic mode of separation utilizing Methanol : Phosphate buffer (0.02M, pH-3.6) in the ratio of 45:55% 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 Nicoumalone. The correlation coefficient was found to be 0.9995 for Nicoumalone. The LOD and LOQ for Nicoumalone were found to be 5.004µg/mL and 15.164µg/mL respectively. The proposed method was found to be good percentage recovery for Nicoumalone, 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: Nicoumalone, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.
Cite This Article:
Please cite this article in press Sunitha et al., A New Analytical Rp-Hplc Method Development And Validation For The Analysis Of Acenocoumarol (Nicoumalone) In Api Form And Marketed Pharmaceutical Dosage Forms.., Indo Am. J. P. Sci, 2026; 13(05).
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