HPTLC method for estimation of tazarotene in topical gel formulations and in vitro study

摘要

A new, eco friendly, simple, and rapid high-performance thin-layer chromatographic method was developed and validated for quantitative determination of tazarotene. The HPTLC separation was achieved on an aluminium-backed layer of silica gel 60F_(254) using toluene-methanol (9.0 +1.0 v/v) as mobile phase. Quantitation was achieved by densitometric analysis at 327 nm over the concentration range of 100-500 ng/mL. The method was found to give a compact spot for the drug (R_f= 0.75 ± 0.01). The linear regression analysis data for the calibration plots showed a good linear relationship with r~2 = 0.9995. 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 18.59 ng/spot, whereas the limit of quantitation was found to be 56.34 ng/spot. Statistical analysis of the data showed that the method is precise, accurate, reproducible, and selective for the analysis of tazarotene. The method was successfully employed for the estimation of equilibrium solubility, quantification of tazarotene as a bulk drug, in commercially available gel preparation and in-house developed microemulsion based gel formulations.