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Background: Lutein, lycopene, and beta-carotene (MiNOXiV) drug combination is used for the treatment of eye diseases including age-related macular degeneration, cataracts, retinitis, retinitis pigmentosa, cancer of the prostate, breast, lung, bladder, ovaries, colon, and pancreas. Objective: The objective of the study was to develop and validate a high-performance liquid chromatographic method for the simultaneous determination of lutein, lycopene, and beta-carotene in tablet dosage forms. Materials and Methods: A Waters C18 column (50 mm × 4.6 mm, 5 μm) with mobile phase consisting of acetonitrile:butanee-1-ol:dichloromethane (70:30:5 [v/v]) was used. The flow rate was 1.0 ml/min and effluents were monitored at 472 nm. Results: The retention time of lutein, lycopene, and beta-carotene in tablet formulation were found to be 7.2 min, 6.0 min, and 10.1 min, respectively. The method was validated according to the ICH guidelines for specificity, limit of detection, limit of quantitation, precision, accuracy, linearity, ruggedness, and robustness. Conclusion: The method showed good reproducibility and recovery with % reflex sympathetic dystrophy <2. Hence, the proposed method was found to be simple, specific, precise, accurate, and linear. Hence, it can be applied for routine analysis of lutein, lycopene, and beta-carotene in pharmaceutical combined dosage forms.
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