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The Thai Journal of Pharmaceutical Sciences

Abstract

Objectives: The objectives of the study are to develop and validate a stability-indicating method for evaluating the stability of extemporaneous oral liquid formulations containing 50 mg/mL isoniazid (INH) prepared from INH drug substances and INH tablets. Materials and Methods: The optimized high-performance liquid chromatography (HPLC) conditions included a C18 column (250 mm × 4.6 mm, 5 μm), a flow rate of 1 mL/min, a column temperature of 30°C, and a detection wavelength of 254 nm. The separations were performed using a gradient HPLC system, employing acetonitrile and water as the mobile phases. The method was validated according to ICH Q2(R1) guidelines. The validated method was applied to assess the INH concentration in extemporaneous oral liquid preparations stored under refrigerated conditions (4 ± 2°C) for duration of 180 days. Results: The optimized method enabled the simultaneous determination of INH and its degradation products in lactose-containing samples. The peak purity index of INH was 1.0000. The linearity assessment over a concentration range of 10–150 μg/mL yielded correlation coefficients (r) surpassing 0.999. Accuracy was observed within the range of 99.24%–100.53%, and the relative standard deviations for intra-day and inter-day precision remained below 1.0%. The investigated formulations contained >93% of the labeled amount of INH throughout the study period, indicating acceptable stability. In addition, no significant changes in pH or color were detected. It was also discovered that the examined commercially available INH tablets are lactose-free formulas. Conclusion: The study reveals that the use of INH substances and lactose-free tablets for oral liquid formulations results in a prolonged stability period than indicated by previous research. This study not only contributes to the validation of a reliable stability-indicating method but it also provides stability data for an extended shelf life of the extemporaneous INH oral liquids, which can improve patient convenience and consequently patient compliance.

DOI

10.56808/3027-7922.2841

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