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

Abstract

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 ¼ 0.75 AE 0.01). The linear regression analysis data for the calibration plots showed a good linear relationship with r 2 ¼ 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.

Stability Indicating Liquid Chromatographic Method for Estimation of Trihexyphenidyl Hydrochloride and Risperidone in Tablet Formulation: Development and Validation Consideration

“…It was demonstrated by repeatability (intraday precision) and intermediate precision (interday precision) of the solutions [12][13][14][15][16].…”

“…The limit of detection (LOD) is the lowest concentration of an analyte that can be reliably differentiated from background levels; limit of quantification (LOQ) of an individual procedure is the lowest amount of analyte that can be quantitatively determined [12][13][14][15][16].…”

“…Robustness of the method was studied by changing the temperature, flow rate of mobile phase, and the pH of mobile phase [12][13][14][15][16]. sets of 250 mL round bottom flasks.…”

“…Commonly used formulation excipients were spiked into a preweighed quantity of drugs. The chromatogram was taken by appropriate dilutions and the quantities of drugs were determined [12][13][14][15][16].…”

“…Linearity Study. Calibration curves were constructed by plotting peak area versus concentrations [12][13][14][15][16] of THP and RSP, respectively, and regression equations were calculated. The calibration curves were plotted over the five different concentrations in range 50-175 g/mL of THP and 50-175 g/mL of RSP.…”