Evaluation and Comparison of Two Spectrophotometric Approaches for Tramadol Hydrochloride Quantification in Pharmaceutical Products
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Tramadol Hydrochloride, Visible Spectroscopy Methods, Validation, Tablet Dosage Forms
Abstract
This study presents a comparative analysis of two visible spectrophotometric methods, referred to as Method A and Method B, for the determination of tramadol hydrochloride. The optimal conditions for the drug analysis were established. For Method A, the maximum absorbance wavelength (λ_max) was 270 nm. Both methods underwent validation in accordance with the ICH guidelines, covering parameters such as linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). Method A demonstrated high sensitivity with a linear range of 30–150 μg/mL and exhibited a strong linear correlation between absorbance and concentration (R² = 0.9993). The regression equation derived from the calibration curve was Y = 0.001x + 0.1482. The accuracy of this method was found to be satisfactory, with excellent reproducibility and recovery, as indicated by a relative standard deviation (RSD) of less than 2%. Method B also exhibited high sensitivity, with a linear range of 10–50 μg/mL at a wavelength of 770 nm and an R² = 0.9997, indicating a reliable linear relationship between absorbance and concentration. The regression equation for this method was Y = 0.002x + 0.1189. Similar to Method A, Method B demonstrated good accuracy, reproducibility, and recovery, with an RSD of less than 2%. Both methods are suitable for the analysis of tramadol hydrochloride in bulk and pharmaceutical formulations, making them appropriate for use in quality control applications. In conclusion, these methods are novel, simple, cost-effective, accurate, and environmentally friendly, offering a reliable approach for the determination of tramadol hydrochloride.
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