Simultaneous determination of ruscogenin, neoruscogenin, trimebutin, and parabens in cream formulation by reverse phase high performance liquid chromatography (RP-HPLC)

Abstract

Abstract A simple and rapid reverse phase high performance liquid chromatography (RP-HPLC) method for analysis of ruscogenin (RUS), neoruscogenin (NRUS), trimebutine (TB), methylparaben (MP) propylparaben (PP) in pharmaceutical preparations has been developed and validated. In this study, a RP-HPLC method was developed for the determination of RUS, NRUS, TB, MP and PP and applied for analysis of pharmaceutical cream formulations. ACE C18 Column 121-2546 (250x4.6 mm) was used at 25 °C and gradient elution was performed with mobile phase consisting of a mixture of ACN:Buffer (pH:3.9). RUS, NRUS, TB, MP and PP eluted within 17 minutes. Peak homogeneity data of RUS, NRUS, TB, MP and PP in the pharmaceutical cream samples peaks obtained using photodiode array detector, in the cream sample chromatograms, demonstrated the specificity of the method. The developed method was validated according to the ICH guidelines. Linear ranges were 1.00, 5.00, 10.0, 25.0, 50.0, 100, 150 μg/mL for MP, RUS and 5.00 – 10.0, 25.0, 50.0, 100, 150, 200 μg/mL for NRUS, PP and 10.0-25.0, 50.0, 100, 150, 200 μg/mL for TB. Validation parameters, such as stability, linearity, sensitivity, accuracy, precision, recovery, robustness and ruggedness were evaluated according to ICH guidelines and the method was simple, rapid, selective, sensitive, accurate, precise, robust and rugged. We developed a fast, low-cost RP-HPLC method with time of 17 minutes for simultaneous analysis of RUS, NRUS, TB and preservatives (MP and PP) in pharmaceutical preparations with semi-solid dosage form. The developed method was successfully applied for the quantification of RUS, NRUS, TB and preservatives (MP and PP) in pharmaceutical preparations with semi-solid dosage form. The detection limit of the method was 0.07, 0.28, 0.07, 0.45, 0.02 µg mL–1 respectively for MP, TB, PP, NRUS and RUS.