Development and Validation of HPTLC Methods for Estimation of Trimebutine Maleate in Pharmaceutical Formulation

Abstract

A simple and rapid high-performance thin-layer chromatographic (HPTLC) method was developed and validated for quantitative determination of trimebutine maleate in single dose formulation. Trimebutine maleate was chromatographed on silica gel 60 F 254 TLC plate using methanol–toluene (8:2 v/v) as mobile phase. The plates were developed to a distance of 8 cm at ambient temperature. Trimebutine maleate was quantified by densitometric analysis at 271 nm. The method was found to give compact spots for the drug (Rf=0.49± 0.01). The linear regression analysis data for the calibration plots showed good linear relationship with R² = 0.999 in the concentration range 50–300 ng/spot. The method was validated for precision, recovery, repeatability, and robustness as per the International Conference on Harmonization (ICH) guidelines. The minimum detectable amount was found to be 1.18 ng/spot, whereas the limit of quantitation was found to be 3.58 ng/spot. Statistical analysis of the data showed that the method is precise, accurate, reproducible, and selective for the analysis of trimebutine maleate.

Keywords: trimebutine maleate, high-performance thin-layer chromatography (HPTLC), validation

Cite this Article

Bhole RP, Jadhav D, Wankhede SB, et al. Development and Validation of HPTLC Methods for Estimation of Trimebutine Maleate in Pharmaceutical Formulation. Research and Reviews: A Journal of Pharmaceutical Science. 2017; 8(1): 17–22p.