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

Abstract

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.