Etravirine Lipid Nanoparticles: Development and Validation Using Specific RP-HPLC Technique
Kunal Badrinarayan Banode *
Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Mahatma Jyotiba Fuley Shaikshanik Parisar, Amravati Road, Nagpur, 440033, India.
Veena Shailendra Belgamwar
Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Mahatma Jyotiba Fuley Shaikshanik Parisar, Amravati Road, Nagpur, 440033, India.
Suchitra Shitla Mishra
Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Mahatma Jyotiba Fuley Shaikshanik Parisar, Amravati Road, Nagpur, 440033, India.
*Author to whom correspondence should be addressed.
Abstract
Introduction: A common, exact & economical reverse phase-high performance liquid chromatographic approach for coinciding measurement of anti-retroviral medicine, Etravirine in the formulation of nanoparticle has been devised. This approach is a revolutionary analytical methodology for detecting substance at the same time.
Methods: Validation & optimization chromatographic conditions were completed as per the guidelines of ICH. The disconnection was done on a column measuring (150mm x 4.6mm, 5μ) using the mobile phase consisted of acetonitrile and 10mM ammonium acetate buffer in the ratio of 90:10 v/v of pH 2.7 as the mobile phase in the ratio 85:15 at a flow rate of 1ml/min for a short run time of 13 minutes. The wavelength was 310nm & the column temperature was kept at 26°C.
Results: The devised technique was linear at 10, 20, 30, 40, as well as 50 g/ml, with a regression coefficient of 0.999 for each of these concentrations. For etravirine, the LOD readings were 0.514 g/ml, whereas the LOQ readings were 1.713 g/ml. Etravirine was shown to have a recovery rate of 98.8%.
Conclusion: The approach was, precise, accurate & rapid with excellent inter- & intra-day accuracy. The approach was also useful for characterization & coinciding measurement of medicines in formulation of nanoparticles.
Keywords: Antiretroviral drugs, etravirine, RP-HPLC, nano formulation, nanoparticles