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Abstract
Sensitive and reproducible reverse-phase high-performance liquid chromatographic and high-performance thin-layer chomatographic methods have been developed for simultaneous estimation of melitracen hydrochloride and flupentixol hydrochloride in bulk and combined tablet dosage form. The methods were validated according to the International Conference on Harmonization guidelines. In the RP-HPLC method, linearity was achieved with a detection range of 50–300 µg/mL (r2 = 0.998) and 2.5–15 µg/mL (r2 = 0.998) for melitracen hydrochloride and flupentixol hydrochloride, respectively. LOD was found to be 1.96 µg/mL and 0.032 µg/mL for melitracen hydrochloride and flupentixol hydrochloride, respectively. LOQ was found to be 5.96 µg/mL and 0.099 µg/mL for melitracen hydrochloride and flupentixol hydrochloride, respectively. In the HPTLC method, linearity was achieved with a detection range of 1600–6400 ng/band [800 µg/mL, 2–8 µ l] (r2 = 0.996) and 80–320 ng/band [40 µg/mL, 2–8 µ l] (r2 = 0.997) for melitracen hydrochloride and flupentixol hydrochloride, respectively. LOD was found to be 27.0 ng/band and 5.02 ng/band for melitracen hydrochloride and flupentixol hydrochloride, respectively. LOQ was found to be 81.81 ng/band and 13.60 ng/band for melitracen hydrochloride and flupentixol hydrochloride, respectively. The proposed methods can be used for estimation of the mentioned drugs in combined dosage form. The results obtained by applying the proposed methods were statistically analyzed.
ACKNOWLEDGMENT
The authors are thankful to Intas Pharmaceuticals (Ahmedabad, India) and Brilliant Pharmaceuticals (Ahmedabad, India) for providing gift samples of standards of drugs.