Determination of Ranolazine in Tablet Formulations by High-Performance Thin-Layer Chromatography-Mass Spectrometry Using Reflectance Scanning Densitometry

摘要

A new quantitative densitometric high-performance thin-layer chromatographic (HPTLC) method was developed and validated for the analysis of ranolazine (RZ) both in bulk and formulations. RZ was separated and identified on silica gel 60 F-254 HPTLC plates with butanol-acetic acid-water (6:2:2 v/v) as the mobile phase. Densitometric quantification was performed at lambda = 270 nm by reflectance scanning which facilitated well-resolved band for the main drug (R-F 0.56 +/- 0.02). Response to RZ was a linear function of concentration in the range of 100-400 ng, with a correlation coefficient, slope, and intercept of 0.99912 +/- 0.00017, 8.684 +/- 0.582, and 492.147 +/- 2.67, respectively. The minimum amount of RZ that could be authentically detected and quantified was 14.90 and 49.67 ng band(-1), respectively. Additionally, the peak identities as well as the purities were confirmed by mass spectrometry. The electrospray ionization (ESI+) mass spectra showed the [M + H](+) ion for RZ detected at m/z 428.3 being acquired directly from the sample bands by an elution-based interface. The proposed method was validated with respect to linearity, precision, accuracy, and specificity.