• Erumalla renuka

A Specific, precise, accurate RP-HPLC method has been developed and validated for the quantitative analysis of Macitentan in tablet formulation. An isocratic separation was achieved using a Zorbax SB C8 (150mm×4.6mm); 5µm particle size column with a flow rate of 1.0ml/min and PDA detector at 215nm. The mobile phase consisted of 0.1%OPA and Acetonitrile (40:60% v/v). The Diluent consisted of pH6.8Phosphate buffer and Acetonitrile in the ratio of 20:80%v/v. The method was validated for specificity, linearity, precision, accuracy and robustness. The specificity of the method was determined by assessing interference from the placebo and by stress testing the drug product (forced degradation). The method was linear over the concentration range 30–150 ppm (r2 = 0.9999). The accuracy of the method was between 98.9–101.6%. The method was found to be Robust and suitable for the quantitative analysis of Macitentan in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Macitentan peak in chromatogram, demonstrating the stability-indicating power of method.

Stability indicating method, Macitentan, RP-HPLC.

"STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF MACITENTAN IN PHARMACETICAL TABLET DOSAGE FORMS BY RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.5, Issue 12, page no.136-145, December-2018, Available :http://www.jetir.org/papers/JETIR1812218.pdf

"STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF MACITENTAN IN PHARMACETICAL TABLET DOSAGE FORMS BY RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.5, Issue 12, page no. pp136-145, December-2018, Available at : http://www.jetir.org/papers/JETIR1812218.pdf