Estimation of Cyproheptadine Hydrochloride and Tricholine Citrate Simultaneously in Syrup Dose by Applying Stability Indicating HPLC Methodology

Abstract

An stability indicating HPLC methodology for the concurrent estimation of Tricholine citrate (TRC) and Cyproheptadine hydrochloride (CYH) in syrup dose and bulk using Waters column reverse phase C18 (5 µm, 250 mm and 4.6 mm) as stationary phase and 0.1M Na₂HPO₄  of pH 4.5 and acetonitrile  in proportion of 60:40 (v/v) at flow of 1.0 ml/min rate as mobile phase was reported. The linear scales were 275-825 µg/ml for TRC and 2-6 µg/ml for CYH with correlation coefficients of 0.9999 for TRC and 0.9997 for CYH. Followed ICH Q2(R1) strategies for validating the suggested method for precision, sensitivity, robustness, specificity, selectivity and accuracy. The measures of LOD and LOQ are 0.023 µg/ml and 0.079 µg/ml for CYH, while for TRC it was 0.565 µg/ml and 1.885  µg/ml,  respectively.   The  precision measures for CYH and TRC were 0.073 and 0.212 relative measured deviation percentage, respectively. The accuracy measures for CYH and TRC were 99.40% and 99.09% mean assay percentiles, respectively. Recovery percentiles measures of CYH and TRC were ranged between 99.48% to 100.35% and 100.38% and 100.41%, respectively. While in degradation investigation, peaks of degraded products are very well differentiated from TRC and CYH peaks suggesting the specificity and stability of suggested methodology. The results permit the application of the proposed stability indicating HPLC methodology in syrup dose forms.