Abstract

STABILITY-INDICATING HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF LOPINAVIR AND RITONAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

Pallavi Mangesh Patil *, Sagar Baliram Wankhede , Praveen Digambar Chaudhari 

ABSTRACT

A novel and quick HPTLC-densitometric method was developed for the simultaneous determination of Lopinavir and Ritonavir. Chromatographic separation of the drugs was performed on precoated silica Tab 60F254 Merck plates using Toluene: Ethyl acetate: Methanol (7:2:0.5:0.5v/v/v) as mobile phase. A TLC scanner set at 254 nm was used. The three drugs were satisfactorily resolved with Rf values of 0.32 ± 0.05, 0.48± 0.05 for Lopinavir and Ritonavir respectively. Calibration curves were polynomial in the range 200- 1000 ng/band, 200-1000 ng/bandfor Lopinavir andRitonavir. Correlation coefficients (r) values were 0.9908, 0.9985, Lopinavir andRitonavir. A low relative standard deviation (< 2%) was found for both precision and robustness study showing that the proposed method was precise and robust. The method had an accuracy of 99.95%, 99.85% of Lopinavir and Ritonavir were validated according to ICH guidelines. The percentage recovery ranges from 99-101%. Forced degradation conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH guideline Q1A (R2). The drug showed instability in oxide and Heat and UV light, while it remained stable in neutral conditions.

Keywords: Lopinavir (LOPI), Ritonavir (RITO), HPTLC, Force degradation studies