Abstract

SIMULTANEOUS ESTIMATION OF LOPINAVIR AND RITONAVIR IN BULK AND DOSAGE FORM BY HPTLC

Jaiprakash N. Sangshetti *, Sachin Bhojane, Baig Salim Rashid, Zahid Zaheer,Rana Z. Ahmed, Indrajeet Gonjari  and Anil P. Battase

ABSTRACT

Simultaneous estimation of Lopinavir and Ritonavir in bulk and formulation by high performance thin layer chromatography (HPTLC) was successfully developed and validated. The chromatographic separation was carried out on pre-coated silica gel aluminum plate 60 F254 (20×20) with 250 μm thickness (Merck, Darmstadt) by using amobile phase composition of Ethyl Acetate: n-Hexane: Acetic Acid (7.0: 2.5: 0.5 (v/v/v). The RF values for Lopinavir and Ritonavir were found to be 0.81 and 0.53 respectively. The linearity of the developed method was found to be within the concentration range of 100-600 ng/spot for Lopinavir and 100-700 ng/spot for Ritonavir. The LOD and LOQ were found to be 6.58, 34.11 ng/spot for Lopinavir and 11.52, 26.22 ng/spot for Ritonavir respectively. Other parameters such as Accuracy, Precision, Specificity, Robustness and Ruggedness were also studied. The developed method is simple, precise, specific and accurate and validated according to the ICH guidelines

Keywords: HPTLC, Lopinavir, Ritonavir, Validation.