Abstract

A simple, precise, and accurate stability-indicating normal-phase HPLC method has been established for simultaneous estimation of Lansoprazole (LANS) and Domperidone (DOMP) in the bulk drug and dosage form. A Phenomenex C-18, 5 µm column having. 250 x 4.6 mm i.d. in isocratic mode with mobile phase containing 20 mM potassium dihydrogen phosphate: acetonitrile (60:40, v/v; pH 6.0) was used. The flow rate was 1.0 mL/min and quantitation was achieved with UV detection at 280 nm. Retention time of LANS and DOMP were 9.98 ± 0.5 min and 5.87 ± 0.5 min respectively. Validation of the method in accordance with ICH guidelines yielded good results for range, linearity, precision, accuracy, specificity, robustness and ruggedness. Response were a linear function of concentration of LANS over the range 3–90 μg mL−1 by peak area with correlation coefficient 0.999 and DOMP over the range 2-60 μg mL−1 by peak area with correlation coefficient 0.998. The limit of detection of LANS was 0.04 μg mL−1 for peak area and the limit of detection of DOMP was 0.19 μg mL−1 for peak area. Results from analysis of a commercial tablet formulation were 99.99 ± 0.1249 % and 99.36 ± 0.0196 % by peak area for LANS and DOMP respectively. Recoveries were 99.87 ± 0.8513 % and 100.17 ± 0.9762 % by peak area for LANS and DOMP respectively. The conditions used also enabled separation and detection of degradation products from acidic, basic, neutral, oxidation stress. No degradation products were obtained after photo and dry heat stress condition.

Key words: HPLC Lansoprazole Domperidone Degradant Validation