Stability-Indicating RP-HPLC Method Development and Validation for Quantification of Butylated Hydroxyanisole Content in Loperamide Oral Solid Dosage Form.

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The present study discusses the development of a simple, rapid, and specific high-performance liquid chromatography (HPLC) method for the estimation of butylated hydroxyanisole (BHA) in loperamide HCl capsule dosage formulations. The developed HPLC method was validated in accordance with current ICH guidelines. Chromatographic separation was achieved using a phosphate buffer (pH 6.8) as mobile phase A and a mixture of acetonitrile and buffer in a ratio of 80:20 (v/v) as mobile phase B. The flow rate was 0.8 mL/min, and column temperature was maintained at 35°C. Detection of the component was performed at 290 nm for BHA. The optimized HPLC method was validated as per current ICH guidelines and demonstrated high specificity with a linearity range of 13-83 μg/mL for BHA, with a correlation coefficient greater than 0.999. The method showed accuracy exceeding 97%. Stress studies revealed that BHA is sensitive to peroxide stress conditions. The results highlight the successful applicability of the current method for estimating BHA in marketed formulations, which can be further utilized to evaluate other formulation systems. The developed method was validated according to international ICH guidelines concerning specificity, linearity, precision, and accuracy. The method was developed and validated in a quality control lab for stability analysis.