ABSTRACT:
A high performance liquid chromatography and high performance thin layer liquid chromatography method were developed and validated for the quantitative determination of Raltegravir potassium in pharmaceutical dosage form. The different analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ) were determined according to the international conference of harmonization ICH 2QB guidelines. In RP-HPLC method the drugs were resolved using a mobile phase at phosphate buffer pH-3.0: methanol (45:55%v/v) with pH adjusted to 3.0 using phosphoric acid on a C18 symmetry (150mmX4.6mm,5µ) column in isocratic mode. The retention time of Raltegravir was 4.3 min. In HPTLC method the chromatograms were developed by using a mobile phase of Toluene: ethyl acetate: methanol: glacial acetic acid (4: 5: 0.6: 0.4%v/v) on precoated plate of silica gel 60F254 and quantified by densiometric absorbance mode at 218nm. The Rf value of Raltegravir was 0.12. Recovery value at 98.36% to100.18%, %RSD of 0.9213 and correlation coefficient (linear dynamic range) at r2=0.9998 shows that the developed methods were accurate and precise. These methods can be employed for the routine analysis of tablets containing Raltegravir potassium.