A Novel Approach for Estimation of Zotepine in Tablet Dosage Form

An antipsychotic medicine zotepine used to treat schizophrenia and mania. A novel stability-indicating method with a reversed-phase ultra-fast liquid chromatography (RP-UFLC) system has been developed to estimate zotepine in dosage forms as tablets. A Shimadzu UFLC system with a Zorbox C18 column and PDA detector was employed for the chromatographic analysis. At 1.0 mL/min flow rate, acetonitrile: 10 mM tetra butyl ammonium hydrogen sulfate (42:58) as a mobile phase. UV wavelength of detection is 221 nm. Concentration range between 0.1 and 50 μg/mL, Beer-Lambert’s law was followed. The linear regression equation was y = 171935x + 11975 (r2 = 0.9999). The limit of detection (LoD) was found to be were 0.0312 μg/mL and limit of quantitation (LoQ) 0.0975 μg/mL. Method validation and a forced degradation study were carried out per ICH guidelines. The proposed approach is straightforward, reliable, accurate, and exact. It can be used to estimate the amount of zotepine in tablets.