Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF MACITENTAN IN TABLET DOSAGE FORM.

Manzoor Ahmed, Deepak.B.M*, Satishkumar Shetty.A, Kuppast I.J, Anilkumar.S.M, M.C Ravi

ABSTRACT

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method with subsequently validate as per ICH guidelines for the determination of Macitentan (MACIT) using mobile phase [mixture of Phosphate buffer pH-3.6 and methanol in the ratio of 35:65] as the solvent. The proposed method involves the measurement of Retention time at selected analytical wavelength. 268.0 nm was selected as the analytical wavelength. The retention time of MACIT was found to be 4.881. The linearity of the proposed method was investigated in the range of 20-100 μg/ml (r = 0.999). The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method.

Keywords: HPLC, Macitentan.