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Abstract

DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE ESTIMATION OF NISOLDIPINE IN PURE AND FORMULATIONS

K. Kamala*, M. Rama Krishna, D. Jeevanmani Babu, M. Nagendra Babu and N. Anil Kumar

ABSTRACT

A simple, precise, rapid and accurate gradient HPLC method has been developed for the estimation of Nisoldipine in bulk and tablet formulations. The chromatographic separation was achieved on Phenomenex C18 (250 mm x 4.6 mm, 5.0 μm) column using the mobile phase composed of acetonitrile : methanol in the ratio of 50:50 (v/v) at a flow rate of 1 mL/min and Nisoldipine was eluted at 3.340 min. Quantification and linearity was achieved at 237 nm within the concentration range of 10-80 μg/ml. The method was validated for specificity, linearity, accuracy, precision, LOD and LOQ as per the ICH guidelines and was found to be suitable to be employed in quality control.

Keywords: RP-HPLC, validation, nisoldipine and tablets.


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