S. Kantha Lakshmi*, C.S. Parameswari, B.V. Ramana, G. Nagarajan
Dr. K.V. Subba Reddy Institute of Pharmacy, Kurnool, Andhra Pradesh, India
A B S T R A C T
The aim present research work to development and validation of RP-HPLC method for the simultaneous estimation of Lumacaftor and Ivacaftor. Chromatographic separation was evaluated by Phenomenex C18 column (250 X 4.6 mm, 5 µ) using the mobile phase consisting of Phosphate buffer and Acetonitrile in the ratio of 40:60%v/v (pH was adjusted to 4.5 with O-phosphoric acid). The mobile phase was pumped at a flow rate of 1.0 mL/min and detection was done by UV detector at 255 nm. The retention time of Lumacaftor and Ivacaftor were found to be 2.857min and 6.329 min. The linearity was obtained in the range of 100-500µg/ml for lumacaftor and 62.5-312.5 µg/ml for Ivacaftor with correlation coefficient was 0.999. The proposed method was found to be simple, accurate, precise, robust and cost effective. It can be applied for routine quality control analysis for simultaneous estimation of Lumacaftor and Ivacaftor in pharmaceutical dosage forms.
Keywords: Lumacaftor, Ivacaftor, RP-HPLC, Mobile phase, Acetonitrile, Retention time