Accuracy

A simple UV–visible spectrophotometric method was developed and validated for the quantitative estimation of sulfamethoxazole in tablet dosage forms in accordance with ICH guidelines (ICH, 2005). The method employs filtered water as solvent and measurement of absorbance at 525 nm, with calibration curves showing good linearity over the concentration range of 5–30 μg mL−1μg mL−1. Absorptivity values were calculated at the selected wavelength. Accuracy, evaluated through recovery studies, showed percent recovery between 98.90 and 99.96% with %RSD values below 2%, confirming the reliability of the method. Precision studies (intra- and inter-day) yielded a %RSD of 0.678, while ruggedness assessment using six replicate absorbance measurements produced a %RSD of 0.253, indicating good robustness. All validation parameters met ICH acceptance criteria, demonstrating that the proposed method is simple, rapid, accurate, precise, and suitable for routine quality control analysis of sulfamethoxazole in pharmaceutical tablet formulations.

ABSTRACTThe aim of the present work was to develop and validate a simple and efficient method for the analysis of Aprepitant in pharmaceutical dosage forms by reverse phase high-pressure liquid chromatography. A stainless steel column 75 mm long, 4.6 mm internal diameter filled with octasilyl silica chemically bonded with synthetic hybrid silica gel particles of 3.5 mm diameter was used for elution. The retention time of Aprepitant was 4.05 min. The method showed a good linearity in the concentration range of 0.02478 – 0.07434 mg/mL with a correlation coefficient of 0.9999. The validation characteristics included specificity, linearity, limit of detection, limit of quantification, precision, robustness and stability. Validation acceptance criteria were met in all cases. The method could be successfully used for the analysis of Aprepitant in pharmaceutical dosage forms. Keywords: Aprepitant, Accuracy, Precision, Linearity, Mobile Phase and Validation