Abstract

DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF TRIFLUOPERAZINE HYDROCHLORIDE AND TRIHEXYPHENIDYL HYDROCHLORIDE IN A SOLID ORAL DOSAGE FORM BY RP-HPLC

*Sree Vidya Parvataneni, Pathuri Jnana Nagarjuna

ABSTRACT

A simple reverse phase liquid chromatographic method has been developed and subsequently validated for simultaneous determination of Trifluoperazine hydrochloride and Trihexyphenidyl hydrochloride in combination. The separation was carried out using a mobile phase consisting of acetonitrile : 0.02 M sodium dihydrogen orthophosphate dihydrate (60:40), pH adjusted to 4.5 with orthophosphoric acid. The column used was Supelco 516 C-18, 25 cm × 4.6 mm i.d., with flow rate of 1 ml / min using PDA detection at 210 nm. The described method was linear over a concentration range of 32-96 μg/ml and 4-12 μg/ml for the assay of Trifluoperazine hydrochloride and Trihexyphenidyl hydrochloride respectively. The retention times of Trifluoperazine hydrochloride and Trihexyphenidyl hydrochloride were found to be 5.4 and 3.5 mins respectively. Results of analysis were validated statistically and by recovery studies. The limit of detection (LOD) and the limit of quantification (LOQ) for Trifluoperazine hydrochloride and Trihexyphenidyl hydrochloride were found to be 0.0015 μg/ml and 0.0010 μg/ml, 0.0045and 0.0032μg/ml respectively. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Trifluoperazine hydrochloride and Trihexyphenidyl hydrochloride bulk drug and in its pharmaceutical dosage form

Keywords: Trifluoperazine hydrochloride, Trihexyphenidyl hydrochloride, RP-HPLC, Pharmaceutical dosage form.