Abstract

Determination of zaleplon in the presence of its degradation products by a stability indicating UPLC method

Author(s): Satheesh kumar shetty, K.V.Surendranath, J.Satish, Johnson Jogul, Upendra ManiTripathi

Anew, simple, sensitive, stability indicating isocraticRP-UPLCassaymethod has been developed for the quantitative determination of Zaleplon in the presence of its degradation products . Efficient Chromatographic separation was achieved on a C18 stationary phase with simple mobile phase Combination of water andMethanol and quantitation was carried out using ultraviolet detection at 230 nmwith a flowrate of 0.4mLmin-1. In the developed UPLC method the resolution (Rs) between Zaleplon and its all degradants obtained from forced degradation studies were found to be greater than 2.0. Regression analysis shows an r2 value (correlation coefficient) of greater than 0.99 for ZaleplonAnd itÂ’s all the degradant impurities. This method was capable to detect the Zaleplon in presence of the Degraded impurities The inter and intra day precision values Zaleplon was found to be within 2.0 %RSD. The method has shown good and consistent recoveries for Zaleplon in bulk drugs (99.3-101.4%). The test solution was found to be stable in diluent for 48 h. The drug substances were subjected to Stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. Considerable Degradation was found to occur in acid stress, base stress and oxidative conditions. The stressed test Solutions were assayed against the qualified working standard of Zaleplon and the mass balance in Each case was close to 99.8% indicating that the developed method was stability-indicating. The Method was developed and optimized by analyzing the forcefully degraded samples The developed RP-UPLC method was validated with respect to linearity, accuracy, precision and ruggedness.