Stability indicating reverse-phase high-performance liquid chromatography method for the determination of Raltegravir in bulk and pharmaceutical formulation

Abstract

Introduction: A new sensitive and simple stability indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the determination of Raltegravir in tablet dosage forms. Materials and Methods: Chromatographic separation was achieved through C8 phenomenex column (250 mm × 4.6 mm i.d., 5 μm particle size) using ammonium formate:acetonitrile (20:80, v/v) mixture as the mobile phase. The Shimadzu Model CBM-20A/20 Alite HPLC system was monitored at detection wavelength 254 nm on isocratic mode with flow rate 1.2 ml/min and the method was validated. Raltegravir was exposed to different stress conditions, and the stability of Raltegravir was studied as per the ICH guidelines. Results and Discussion: Raltegravir follows Beer-Lambert’s law over a concentration range 1–120 μg/ml with regression equation y = 15416x+10312 and correlation coefficient 0.9997. The limit of detection and limit of quantification are found to be 0.2885 μg/ml and 0.8743 μg/ml, respectively. Raltegravir was found to be more sensitive toward alkaline conditions. Conclusions: The proposed RP-HPLC method is accurate, precise, sensitive, and specific for the assay of Raltegravir in tablets.