Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF TADALAFIL

Vikram A. Madane*, Dr. N. M. Bhatia and Dr. D. A. Bhagwat

ABSTRACT

A novel, simple, selective, linear, accurate and precise reverse phase high performance liquid chromatography method was developed for estimation of tadalafil in bulk and tablet dosage form. For HPLC method, Agilent Eclipse C8 (150×4.6 mm 5 μm) column are used. The mobile phase containing Phosphate Buffer 3.5: Acetonitrile: Methanol (50:40:10 v/v) was used. The flow rate was 1 ml/min and detection wavelength was at 285 nm at 40˚c temperature. The injection volume of sample is 20 μl and the run time is 6 min. The retention time (R2) was found to be 3.450 min and %y intercept -0.1952%. The linearity range should be 160.0 to 240.0 ppm. As soon as mobile phase is filtered through 0.45 micron nylon filter paper. Method was validated in terms of specificity and system suitability, linearity, range, accuracy, precision, LOD, LOQ and robustness as per ICH guidelines. Results of the analysis show that the method can be used for the estimation of tadalafil in tablet dosage form.

Keywords: Method development, Estimation, Validation, Tadalafil, RP-HPLC.