Abstract
A novel stability indicating reverse phase ultra performance liquid chromatographic (UP-LC) method has been developed for Etravirine along with eight impurities (imp-1, imp-2, imp-3, imp-4, imp-5, imp-6, imp-7 and imp-8) and validated as per ICH recommendations. Stress degradation conditions were established for Etravirine by subjecting it to stress conditions of acid, base, oxidation, humidity, thermal and photolysis. Significant degradation is observed in base stress condition and the major degradant (RRT at about 0.94) is identified by LC-MS and spectral analysis. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 99.0%. Efficient chromatographic separation was achieved on a Shimpack ODS-II stationary phase with a gradient mobile phase combination. Quantification was carried at 303 nm at a flow rate of 0.6 mL?min–1. The resolution between Etravirine and eight potential impurities is found to be greater than 2.0. Regression analysis shows as r value (correlation coefficient) of greater than 0.999 for Etravirine and eight potential impurities. This method is capable to detect the impurities of Etravirine at a level of 0.003% with respect to test concentration of 1.0 mg·mL–1.
Highlights
During the past decade HIV infection has become, at least in developed countries, a largely manageable but incurable disease. This is due to the advent of Highly Active Anti Retroviral Therapy (HAART), in which patients are treated with a cocktail of drugs designed to reduce their viral loads to extremely low levels [1]
Degradation is not observed in Etravirine stressed samples subjected to light, humidity, heat, acid and oxidative stress conditions
The gradient ultra performance liquid chromatographic (UP-LC) method developed and used for stress studies fit for quantitative, related substance and assay determination of Etravirine
Summary
During the past decade HIV infection has become, at least in developed countries, a largely manageable but incurable disease. This is due to the advent of Highly Active Anti Retroviral Therapy (HAART), in which patients are treated with a cocktail of drugs designed to reduce their viral loads to extremely low levels [1]. When a CD4 cell in a person’s body effected by HIV, it copies its own genetic code into the cell’s DNA. The genetic material of HIV is in the form of RNA In order for it to infect CD4 cells, it must first convert its RNA into DNA.
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