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

Abstract

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

Development and validation of a stability-indicating assay method for determination of metronidazole benzoate in bulk: Spectroscopic approach

“…Spectrophotometric stability method may have advantages over chromatographic techniques in terms of simplicity, economic and time consumption. In degradation study, the intensity of stress parameters depends on physicochemical properties of drug substance and nature of drug or product 13,14 . In the Pharmaceutical industry time and expanses plays an important role hence simple, cost effective and more sensitive methods are highly acceptable for routine usage of study.…”