ABSTRACT

There have been several reports of spectrophotometric and HPLC techniques for determining the amount of tamsulosine in medications and dosage formulations. Therefore, a novel, sensitive, appropriate, and reliable reversed-phase high-performance liquid chromatography method was created and verified in this study to measure tamsulosine in tablet and bulk medication formulations and quality by design is to cross check the calculated results with the help of DOE software. Using an Openlab EZchrome software-equipped UV detector and a Kromasil C18, 250 mm X 4.6 mm, 5 ?m column, methanol and water (75:25% v/v) were employed as the mobile phase in the RP-HPLC procedure. The flow rate of the column was 1.0 ml/min. To detect, 224 nm was used. The technique produced an appropriate retention period for tamsulosine or 3.60 minutes. The validity of the analysis results in the following areas was confirmed: robustness; limit of detection; limit of quantification; filter study; stability of the solution; specificity; linearity; accuracy; precision (repeatability and intermediate precision); and more. The assay of tamsulosine in tablet and bulk medication formulations was straight forward and accurate. The technique is less time-consuming and requires frequent reagents for analysis; it can be used in the industry to analyze marketed tamsulosine products and bulk drugs. Keywords: RP-HPLC, Tamsulosine, Validation, QbD, Box-Behnken design, DOE
Publication date: 01/11/2025

https://ijbpas.com/pdf/2025/November/MS_IJBPAS_2025_9589.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.11.9589