Development and Validation of Stability Indicating Assay Method of Doxycycline Hyclate by using UV-Spectrophotometer

In the present study a simple, rapid, sensitive, and cost-effective stability indicating UV- spectrophotometric method was developed of doxycycline hyclate in bulk form validated as per ICH guidelines. The stability-indicating based on forced degradation reactions drug under different ICH-prescribed stress conditions like acid, alkali, neutral, oxidation, thermal, photolysis. absorption maximum shown at 270nm methanol selected solvent basis solubility drug. A linear relation with regression coefficient value (R2) 0.999 indicates that follows Beer’s- Lambert’s law within concentrations range 5 - 50µg/ml. detection limit quantitation were found to be 0.53 µg/ml 1.55 respectively. % recoveries 98.87 -99.88 low RSD accuracy for estimation Under stressed conditions, significant neutral oxidation sensitive thermal photolytic but stable acidic hydrolytic conditions. according guidelines accurate, precise, specific, suggesting spectroscopic could successfully adopted estimate hyclate.
 Keywords: Doxycycline Hyclate; Stability Indicating method; UV spectrophotometer; Validation; Stress degradation.