RP HPLC Method Development and Validation for Estimation of Orlistat in Pharmaceutical Dosage Forms

Orlistat is an anti-obesity drug that inhibits the secretion of gastric and pancreatic lipases. Normally lipase breakdown triglyceride in intestine as a result metabolism. Despite numerous advantages this drug, researchers are facing problems with estimation by HPLC because limited methods available; only United State Pharmacopoeia (USP) method most reliable effective. The present work aimed to develop RP- for determining orlistat floating microcapsules. Considering virtual reality testing, quality control dosage forms main criterion be followed Pharmaceutical industry, which establish procedures undertaken ensure identity purity particular form. Syncronis C18, 150mm x 4.6mm, 3μm column were used. Isocratic elution was performed ACN:Water mixture. flow rate 2.0 mL min-1 UV detection at 205 nm. Caffeine used internal standard. developed validated according ICH guidelines found linear within range 150-600 ppm Orlistat. In addition, its suitability, accuracy, precision, selectivity, robustness, ruggedness per guidelines. results analytical validation suitable quantitative qualitative analysis it showed could successfully utilized identification quantification any form, high resolution, precision.