Formulation development and validation of analytical technique for novel drug

Abstract

Nanoparticles are one of the novel drug delivery system that releases the drug for a prolonged period of time. This dosage is associated with many advantage especially increase bioavailability and reduction in dosage frequency and decrease the risk of adverse side effects. The present work was proposed to prepare nanoparticles loaded with Abacavir sulfate newlineand Ritonavir using solvent evaporation method and emulsion polymer cross linking method. newlineThe entrapment efficiency and cumulative percentage of drug release from the formulation AF6 and BF6 showed better results in polymer cross linking method. Among the several parameter, the polymer concentration played on important role in entrapment efficiency, from the above study it was found that the entrapment efficiency of the drug was increased with the increasing concentration of the polymer. The shape of nanoparticles was found to be nearly spherical with smooth surface by SEM and TEM analysis. Polydispersity index of formulation AF4 to AF6 and BF4 to BF6 are within the limit. The best formulation AF6 and BF6 was selected for the invivo study. These pharmacokinetic studies revealed significantly greater extent of absorption of Abacavir sulfate and Ritonavir nanoparticle than the oral tablet formulations. The absorption of Abacavir sulfate and Ritonavir nanoparticle resulted in increases in bioavailability as compared to the oral tablet formulations. Results of the studies indicates that nanoparticles can be successfully used for enhancement of bioavailability of formulations AF6 and BF6. A new analytical method was developed and validated. The estimation of Abacavir sulfate and Ritonavir was achieved by UV method, after considering the solubility and stability, phosphate buffer (pH 7.4) was selected as solvent and the 284 nm and 243 nm was selected wave length for analysis. Further precision of the method was studied by intraday and interday analysis. The percentage R.S.D. was found to be 0.46799 and 0.38445 and the lower percentage R.S.D. indicates that the method is highly precise.