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Published on:August 2016
Indian Journal of Pharmaceutical Education and Research, 2016; 50(3):403-408
Original Article | doi:10.5530/ijper.50.3.13

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

Authors and affiliation (s):

Thota Anusha*1, 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.


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.

Key words: Nicoumalone, RP-HPLC method and Validation, ICH, Estimation, Dosage Form.



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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.


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