Stability Indicating RP-HPLC Method for the Estimation of ORLISTAT in Bulk and Pharmeceutical Dosage Forms

Abstract

The current research goal was to develop a novel specific procedure for the
quantitation of the Orlistat. The method development was done by using a HighPerformance Liquid Chromatography (HPLC). The extensive method development was
conducted to identify a right combination of chromatographic conditions and validated as
per the regulatory guidelines. The current method overcome the disadvantages of other
methods likewise UV and potentiometric titrations. The mixture of mobile phase A and B
(50:50) used to elute the Orlistat in isocratic mode. The rapid run time of the method was
accomplished by adjusting the flow rate of 2.0mL per minute along with L1-octadecyl
chemistry column. The Orlistat peak was detected by using a sensitive Ultra violet detector
at 205nm. The method was completely screened with all the key validation parameters
likewise suitability, precision, selectivity, linearity, robustness and recovery. The purity
threshold of more than 990 proves that the method is free from any possible interferences
and the linearity was established at 5 different levels with a correlation coefficient 0.998.
The overall %RSD (relative standard deviation) of mean recovery was 0.70%. The
marketed commercial formulation of Orlistat capsules was tested on the developed method
to confirm the suitability of the method for both bulk active substance and pharmaceutical
formulations. Based on the experimental outcome method can be regarded as inventive,
and specific to quantitate Orlistat. The developed method can be used directly to test the
pharmaceutical formulations and drug substances. Further these methods can be modified
to determine the impurities in drug substances and drug products