Development of LC Method for the Simultaneous Determination of Antidepressant Drug Combination Melitracen Hydrochloride and Flupentixol Dihydrochloride in their Combined Dosage Form

Usmangani K Chhalotiya,Dimal A Shah,Gautam R Chauhan,Sunil L Baldania,Kashyap K Bhatt

doi:10.4061/2011/632820

Usmangani K Chhalotiya, Dimal A Shah + Show 3 more

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https://doi.org/10.4061/2011/632820

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Abstract

A simple, specific and stability-indicating reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of melitracen hydrochloride and flupentixol dihydrochloride in tablet dosage form. A Brownlee C-18, 5 μm column having 250×4.6 mm i.d. in isocratic mode, with mobile phase containing 0.025 M potassium dihydrogen phosphate: methanol (10 : 90, v/v; pH 7.3) was used. The flow rate was 1.0 mL/min, and effluents were monitored at 230 nm. The retention times of melitracen hydrochloride and flupentixol dihydrochloride were 7.75 min and 5.50 min, respectively. The linearity for melitracen hydrochloride and flupentixol dihydrochloride were in the range of 0.5–60 μg/mL. The recoveries obtained for melitracen hydrochloride and flupenthixol dihydrochloride was 99.81–100.77% and 99.42–100.12%, respectively. Both the drugs were subjected to acid and alkali hydrolysis, chemical oxidation, and dry heat degradation and photodegradation. The proposed method was validated and successfully applied to the estimation of melitracen hydrochloride and flupentixol dihydrochloride in combined tablet dosage form.

Highlights

Melitracen hydrochloride (MEL) is a white to off white powder and amorphous in nature
Excess amount of dopamine receptors normally act to modify behavior and overstimulation resulting in psychotic illness
The combination of FLU and MEL is indicated in the treatment of trigeminal neuralgia [5]

Summary

Introduction

Melitracen hydrochloride (MEL) is a white to off white powder and amorphous in nature It is 3-(10, 10-dimethyl anthracen-9-ylidene)-N, N-dimethylpropan-1amine) [1, 2] (Figure 1(a)). Flupentixol dihydrochloride (FLU) is white or almost white powder It is (Z)-4-[3-[2-(Trifluoromethyl)-9H thioxanthen9-ylidene] propyl]-1-piperazin ethanol dihydrochloride [3] (Figure 1(b)). Mobile phase was prepared by accurately weighing 0.340 g of potassium dihydrogen phosphate and dissolving in 100 mL of water It was mixed with 900 mL of methanol, and pH was adjusted to pH 7.3 using triethylamine (TEA). Appropriate aliquots of MEL working standard solution were taken in different 10 mL volumetric flasks. Appropriate aliquots of FLU working standard solution were added to the same flasks.

Experimental

Results and Discussion

Conclusion