Rapid RP-HPLC Method Development and Validation for Analysis of Raltegravir in Bulk and Pharmaceutical Dosage Form Sri K. Vijaya*, Ravinderreddy S., Suresh K. Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, Maisammaguda, Secunderabad-500 014, Telangana, India *Corresponding Author E-mail: vijayasree_2002@yahoo.co.in
Online published on 25 June, 2015. Abstract A simple, precise, accurate and robust RP-HPLC-UV method was developed and validated for the determination of Raltegravirin bulk and pharmaceutical dosage forms. Reverse-phase chromatography was performed on Agilent (100 mm × 2.5 mm, 3μm) column of C18 HPLC with EZ Chrome software with UV detector. Acetonitrile: water (80:20) (v/v) was used as mobile phase at a flow rate of 0.8 mL min−1 with UV detection at 240 nm. Linearity was observed in the concentration range of 25– 200μg mL−1 with regression co-efficient (R2 = 0.999). The method was validated as per ICH guidelines. The RSD for intra-day (0.015) and inter-day (0.005) precision were found to be less than 2%. The percentage recovery was in good agreement with the labelled amount in the pharmaceutical formulations and the method is simple, precise, accurate and robust for the determination of Raltegravirin bulk and pharmaceutical dosage forms. Top Keywords Raltegravir, RP-HPLC-UV, Method validation, Tablets. Top |