Abstract

Purpose: To develop simple and reliable quantitative methods for the determination of cilnidipine (CLD) in pharmaceutical tablets.Methods: Two simple and sensitive methods (spectrophotometric and spectrofluorimetric) were developed for the determination of cilnidipine (CLD) in pure form and in a pharmaceutical preparation. Spectrophotometric method (A) is based on oxidation of CLD with a known excess amount of Nbromosuccinamide (NBS) in acidic medium, followed by addition of methyl orange indicator and absorbance measurement at 510 nm. The spectrofluorimetric method (B) is based on oxidation of CLD to cerium (IV), followed by measurement of fluorescence emission of Ce (III) at 350 nm. Factors that affect the performance of the two methods were studied and optimized.Results: The spectrophotometric and spectrofluorimetric procedures were successfully used for measuring CLD levels in pharmaceutical dosage form, in the ranges of 2.0 - 25.0 and 0.25 - 11.2 μg/mL, at detection limits of 1.05 and 0.13 μg/mL, respectively. There were no significant differences between the proposed methods and a standard reference method (p < 0.05).Conclusion: The developed methods provide simple and reliable procedures for quantitative measurement of CLD in bulk and tablet forms.
 Keywords: Cilnidipine, Oxidation, Spectrophotometric, Spectrofluorimetric, Drug formulation

Highlights

  • Cilnidipine (CLD) (Figure 1) is a unique 1,4dihydropyridine derivative and Ca2+ channel blocking agent with potent inhibitory effects on Ltype and N-type voltage-dependent calcium channels [1]

  • NBS was used as a bromination agent for the studied drug, with the bromination taking place on the double bond attached to the phenyl group of CLD

  • The principle of the proposed method involves indirect spectrophotometric analytical method based on the oxidation of CLD with a slight excess of NBS

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Summary

Introduction

Cilnidipine (CLD) (Figure 1) is a unique 1,4dihydropyridine derivative and Ca2+ channel blocking agent with potent inhibitory effects on Ltype and N-type voltage-dependent calcium channels [1]. Cilnidipine (CLD) is a fourthgeneration 1,4-dihydropyridine derivative used in the treatment of hypertension It depresses sympathetic nervous system activity and reduces the associated adverse effects, with good therapeutic outcome. It has some advantages over old generation treatments [2]. There are limited analytical procedures for quantification of CLD in its pure and tablet forms. These methods are UV-VIS spectrophotometry [3,4,5,6], HPLC [7,8,9,10], and electrochemistry [11]

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