Development and validation by statistical treatment of stability indicating RP-HPLC method for quantification of Orlistat in Orlistat-loaded solid dispersion

Abstract Background Most of the analytical methods reported for estimation Orlistat were complex, expensive, and deficient in reproducibility with no or very less informative regarding various statistical equations used validation purpose. This study provides a fast, accurate, descriptive, precise isocratic reversed phase high-performance liquid chromatographic (HPLC) method using Waters Spherisorb 5 μm Octadecyl-silica-2 (250 × 4.6 mm) column, bulk drug pharmaceutical formulations minimized extraction steps. The was detected an column mobile comprising mixture methanol, acetonitrile, 2% phosphoric acid ratio 85:14:1 v/v/v at flow rate 1 ml/min elution monitoring 215.0 nm. Results retention time found to be 5.9 min sharp proper peak. linearity covered over concentration range 1.00–10.00 μg/ml ( r 2 = 0.9997) limit detection quantitation 0.06 0.2 μg/ml, respectively. developed technique validated all parameters within acceptance criteria ICH guidelines. mean ± standard deviation (SD) recoveries 99.87 0.45. Conclusion optimized well precise, sensitive, stability indicating, tested parameters. Thus, can conveniently quality control routine analysis containing solid dispersions other formulations. main advantage its high specificity presence degradation products resulting from stress conditions formulation excipients.