Application of Plackett-Burman and central composite designs for screening and optimization of factor influencing the chromatographic conditions of HPTLC method for quantification of efonidipine hydrochloride

Suraj R Chaudhari,Atul A Shirkhedkar

doi:10.1186/s40543-020-00246-2

Suraj R Chaudhari, Atul A Shirkhedkar

Open Access

https://doi.org/10.1186/s40543-020-00246-2

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Abstract

We report here an analytical method for expeditious estimation of efonidipine hydrochloride in tablet formulation with statistical screening and optimization designs using NP-HPTLC. TLC silica gel 60 F254 aluminum plates and ethyl acetate to dichloromethane to triethylamine (3:2:0.5 v/v) were chosen for chromatographic separation of efonidipine hydrochloride. The Rf value for efonidipine hydrochloride turned out to be 0.35 ± 0.25 and quantitative evaluation was done at 251 nm. Plackett-Burman and face-centered central composite design (CCD) were used to obtain the most peak area and well-resolved compact band with an adequate retention factor of efonidipine hydrochloride. Plackett-Burman design at two-level with six independent variables has been employed for screening of prominent factors that affect the responses. The prominent factors have been selected and are optimized through face-centered CCD. The results obtained from face-centered CCD showed that most peak area can be obtained with development distance 8.50 cm and chamber saturation 17 min. Furthermore, the current NP-HPTLC investigation has been validated according to the ICH guidelines for accuracy, precision, sensitivity, robustness, ruggedness, and specificity. The detection and quantification limit was found that 10.41 ng and 31.57 ng, suggesting that the analysis could be accurately and precisely detected the analyte up to nanogram quantity. The current NP-HPTLC investigation is rugged, accurate, and highly sensitive and could be used for routine analysis of efonidipine hydrochloride.

Highlights

Efonidipine hydrochloride (EFH) is a dihydropyridine class of the calcium channel blocker chemically 2-[benzyl(phenyl)amino]ethyl 5-(5,5-dimethyl-2-oxo-1,3,2lambda5-dioxaph osphinan -2-yl)-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydroEFH blocks Ca2+ channels of types L and T as a result of that vasodilation and decreased automaticity of the heart and causes negative chronotropic effect and lower the heart rate (Tanaka and Shigenobu 2002).From the other instrumental techniques of pharmaceutical analysis, high-performance thin-layer chromatography (HPTLC) is the most significant technique because the advances in the stationary phase and the commencement of densitometric detection are increasingly being used nowadays in the area of drug analysis
Optimization of mobile phase composition The selection and optimization mobile phase is a crucial step in TLC method development because it affects the quality of separation (Shewiyo et al 2012)
In the first two systems, EFH remained as it is without any movement, while it is coeluted within the third system

Summary

Introduction

Efonidipine hydrochloride (EFH) is a dihydropyridine class of the calcium channel blocker chemically 2-[benzyl(phenyl)amino]ethyl 5-(5,5-dimethyl-2-oxo-1,3,2lambda5-dioxaph osphinan -2-yl)-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydroEFH blocks Ca2+ channels of types L and T as a result of that vasodilation and decreased automaticity of the heart and causes negative chronotropic effect and lower the heart rate (Tanaka and Shigenobu 2002).From the other instrumental techniques of pharmaceutical analysis, high-performance thin-layer chromatography (HPTLC) is the most significant technique because the advances in the stationary phase and the commencement of densitometric detection are increasingly being used nowadays in the area of drug analysis. Efonidipine hydrochloride (EFH) is a dihydropyridine class of the calcium channel blocker chemically 2-[benzyl(phenyl)amino]ethyl 5-(5,5-dimethyl-2-oxo-1,3,2lambda5-dioxaph osphinan -2-yl)-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydro. The “trial and error” strategy has been used for long years to optimize these controllable variables; this approach comprises of changing one variable at a time whereas other variables have to maintain steady to get efficient separation of pharmaceuticals. This traditional approach can consume a lot of time and money to optimize the robust conditions for the analysis of pharmaceuticals

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