Simultaneous Quantitation Tramadol Hydrochloride and Diclofenac Sodium by RP-HPLC in Fixed-dose Combination(FDC)

The concurrent detection of tramadol hydrochloride and diclofenac sodium in their mixed dosage form as tablet was developed and validated using a simple, accurate, inexpensive, and precise RP-HPLC approach with a UV-Visible detector. Enable C18 G analytical column (250 x 4.6 mm, i.d., 5 μm) was used for the separation. The mobile phase was made of a mixture of 80 volumes of acetonitrile and 20 volumes of 1 % v/v glacial acetic acid. Isocratic elution was utilised at a flow rate of 1 mL/min during the chromatographic process. Tramadol hydrochloride and diclofenac sodium were identified at UV detector wavelength of 264 nm and established linear calibration curves with concentration ranges of 20–100 μg/ml and 15–75 μg/ml, respectively. Tramadol hydrochloride had recoveries of 99.62–99.86% and diclofenac sodium had a recoveries of 99.48-100.22%. The approach was validated in the context of the International Conference of Harmonisation's requirements for accuracy, precision, specificity, robustness, limits of detection and quantification. The precision studies for both drugs were found to be < 2% (%RSD). The limits of detection for tramadol hydrochloride and diclofenac sodium were found to be 0.12 μg/ml and 0.07 μg/ml, respectively. The limits of quantification for tramadol hydrochloride and diclofenac sodium were found to be 0.45 μg/ml and 0.21 μg/ml, respectively. Both tramadol hydrochloride and diclofenac sodium, two commercial pharmaceutical drugs, were effectively analysed using high-performance liquid chromatography using the described approach.