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

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 F254 HPTLC plates with butanol—acetic acid—water (6:2:2 v/v) as the mobile phase. Densitometric quantification was performed at λ = 270 nm by reflectance scanning which facilitated well-resolved band for the main drug (RF 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.