RESUMEN
Aims: A simple RP-TLC Spectrodensitometric method was developed for determination of Hyoscine N-Butyl Bromide (HBB) and Paracetamol (PAR) either in bulk powder or in their pharmaceutical preparation. Study Design: Validation study. Methodology: In this method, HBB and PAR were separated on RP-18 W/ UV254 TLC plates using developing mobile phase consisting of methanol: citrate buffer (pH=1.5): triflouroacetic acid (70:30:0.1, by volume) at room temperature. Experimental conditions such as band size, slit width, different developing systems and scanning wavelength were carefully studied and the optimum conditions were selected. The obtained bands were then scanned at 210 nm. The two drugs were satisfactorily resolved with RF 0.60 ± 0.02 for HBB and 0.81 ± 0.02 for PAR. The validation of spectrodensitometric method was done regarding linearity, accuracy, precision, and specificity. Results: Linearity of the proposed methods was evaluated and it was found to lie within the concentration range of 2.0-12.0 μg.band-1 for HBB and 2.0-14.0 μg.band-1 for PAR. Conclusion: The proposed method was successfully applied for determination of HBB and PAR in pure form and in their different pharmaceutical formulations. The method proved to be specific, accurate and selective.