ISSN : 2663-2187

Development and Validation of analytical method for parenteral drug Nicardipine by using HPLC

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Mr. Narendrakumar D. Phupate, Dr.Vilas N. Deshmukh
» doi: 10.48047/AFJBS.6.12.202 4.6694-6705

Abstract

Nicardipine is a second-generation dihydropyridine calcium channel blocker. It is often used in the treatment of hypertension, angina pectoris and associated cardiovascular conditions. The study was conducted to develop and validate a precise, simple and rapid RP-HPLC method for the estimation of Nicardipine in bulk and parenteral formulation. Study was performed with column (Symmetry C18 (4.6 x 250mm, 5μm). A Methanol: Buffer (Pot. Dihydrogen Phosphate (0.1M) (80:20 v/v) was used to create an isocratic mobile elution phase. A UV detector was used for 254 nm detection, which had an 20 μL injection volume, a flow rate of 1.0 mL/min, and an 40℃ column temperature. Nicardipine was found to have retention time of 7.118 minute. The approach was validated for accuracy, specificity, selectivity, precision, linearity, sensitivity and robustness. Plots of linear calibration were made for concentrations between 25 and 125 µg/mL. The correlation coefficient (r²) for the proposed approach was determined to be 0.998. Evaluation of system and method accuracy revealed that the technique is accurate within the acceptable range. In particular, the number of theoretical plates, tailing factor, and RSD were calculated for both solutions. It was evident from the results that the suggested method works well for the quick, precise, and accurate measurement of Nicardipine.

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