DEVELOPMENT AND VALIDATION OF REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC AND HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHIC METHODS FOR SIMULTANEOUS ESTIMATION OF MELITRACEN HYDROCHLORIDE AND FLUPENTIXOL HYDROCHLORIDE IN BULK AND COMBINED DOSAGE FORM

• Published in: Journal of liquid chromatography & related technologies Vol. 35; no. 19; pp. 2753 - 2764
• Main Authors: Limgavkar, Ratna S., Trivedi, Priti D., Patel, Archita J.
• Format: Journal Article
• Language: English
• Published: Colchester Taylor & Francis Group 01.01.2012; Taylor & Francis; Taylor & Francis Ltd
• Subjects: Analysis; Biological and medical sciences; Chromatography; Conferences; Dosage; flupentixol hydrochloride; General pharmacology; Guidelines; HPTLC method; Hydrochlorides; ICH Guideline; Linearity; Liquids; Medical sciences; melitracen hydrochloride; method validation; Pharmacology. Drug treatments; RP-HPLC method; Tablets; Validation; method validation; High performance thin layer chromatography; Chemical analysis; Thioxanthene derivatives; Neuroleptic; Psychotropic; HPLC chromatography; Oral form; HPTLC method; ICH Guideline; Tricyclic compound; flupentixol hydrochloride; Reversed phase chromatography; Bulk material; Ultraviolet detector; melitracen hydrochloride; Melitracen; Simultaneous measurement; Dosage form; Antidepressant agent; Tablet; RP-HPLC method; Flupentixol
• ISSN: 1082-6076; 1520-572X
• DOI: 10.1080/10826076.2011.639111

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 (r 2  = 0.998) and 2.5-15 µg/mL (r 2  = 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] (r 2  = 0.996) and 80-320 ng/band [40 µg/mL, 2-8 µ l] (r 2  = 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.