Article · Volume 50, Issue 3 · pp. 403–408

A Novel RP-HPLC Method Development and Validation for Estimation of Nicoumalone in Bulk drug and Formulation

Thota Anusha¹, Thota Prasad¹, Valluri Asha Ranjani², Sahu Puranlal¹, Kumar Robin¹, Singh Gyanendra Nath¹

¹Reference Standard Division, Indian Pharmacopoeia Commission, Ghaziabad-201002, INDIA.
²Department of Pharmaceutical Analysis, MLR Institute of pharmacy, Dundigal-500043, INDIA.

Abstract

Objective: The objective of this study is to validate a simple, precise, and accurate isocratic reverse phase high performance liquid chromatography (RP-HPLC) method for estimation of nicoumalone in bulk and tablet dosage form. Method & Results: The quantification is carried out by using C18 column (inertsilR ODS-3V column, 250¥4.6 mm, 5 μm). A mixture of Acetonitrile: Potassium dihydrogen phosphate buffer 10 mM, pH 6 adjusted using 0.1 N KOH in 50:50 v/v ratio used as mobile phase. The flow rate was set at 1 ml/min and the Separation performed at ambient temperature. UV detector set at 283 nm. The retention time of nicoumalone found to be 4-5 minutes. Method Validation: Validation of proposed method is done as per International Conference of Harmonization guidelines (ICH). The analytical parameters are statistically validated for linearity and range, precision, limit of detection, limit of Quantitation, accuracy, and robustness.Conclusion: The proposed method is useful for best analysis of pharmaceutical dosage forms.

Keywords: Nicoumalone; RP-HPLC method and Validation; ICH; Estimation; Dosage; Form

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