A simple, precise, and accurate stability-indicating normal-phase HPTLC method has been established for simultaneous estimation of Lansoprazole (LAN) and Domperidone (DOM) in the bulk drug and dosage form. Chromatography was performed on silica gel 60F254 with toluene: methanol 8:2 (v/v) as mobile phase. Densitometric quantification was performed at 295 nm by reflectance scanning. The RF value of DOM and LAN were 0.34 ± 0.03 and 0.50 ± 0.03 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 LAN over the range 375–3000 ng/band by peak area with correlation coefficient 0.99693 and DOM over the range 250–2000 ng/band by peak area with correlation coefficient 0.99372. The limit of detection of LAN was 1.70 ng per band for peak area and the limit of detection of DOM was 4.06 ng per band for peak area. Results from analysis of a commercial tablet formulation were 100.62 ± 0.0357 % and 100.00 ± 0.0388 % by peak area for LAN and DOM respectively. Recoveries were 100.06 ± 0.4690 % and 99.66 ± 0.2482 % by peak area for LAN and DOM 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: HPTLC, Lansoprazole, Domperidone, Degradant, Validation
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