HPTLC method development and validation: Quantification of paliperidone in formulations and in vitro release study

Abstract

A new, economic, environmentally friendly and rapid high-performance thin-layer chromatographic (HPTLC) method was developed and validated for quantitative determination of paliperidone. The HPTLC separation was achieved on an aluminium-backed layer of silica gel 60F₂₅₄ using methanol–ethyl acetate (8.0 + 2.0 v/v) as mobile phase. Quantitation was achieved by densitometric analysis at 284 nm over the concentration range of 100–600 ng mL⁻¹. The method was found to give compact spot for the drug (R_f 0.54 ± 0.011). The linear regression analysis data for the calibration plots showed good linear relationship with r² = 0.9997. The method was validated for precision, recovery, repeatability, and robustness as per the International Conference on Harmonization guidelines. The minimum detectable amount was found to be 15.11 ng/spot, whereas the limit of quantitation was found to be 45.79 ng/spot. Statistical analysis of the data showed that the method is precise, accurate, reproducible, sensitive and selective for the analysis of paliperidone. The method was successfully employed for the estimation of paliperidone as a bulk drug, equilibrium solubility study, commercially available tablet formulation, mucoadhesive microemulsion formulations and solution (developed in-house).