Stability Indicating Analytical Method Development and Validation for Estimation of Orlistat in Bulk and its Dosage form by HPTLC Technique and Finding Degradants by LC-MS.

A new simple, accurate, precise and selective stability indicating high performance thin layer chromatographic method has been developed and validated for estimation of Orlistat Tablet.T he mobile phase selected was Toluene: Methanol(8:2v/v) with UV detection at 211nm.The retention factor for Orlistat was found to be 0.60±0.02. The method was validated with respect to linearity, accuracy, precision and robustness as per the ICH guidelines. The drug were subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Results found to be linear in concentration range of 6000-36000 ng/band. The thermal method has been successfully applied for the analysis of drug in pharmaceutical formulation. The % assay (Mean ± S.D) was found to be 99.30±1.10.The developed method can be used for checking the stability of  Orlistst in bulk drug and pharmaceutical dosage form.