A RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF HALOPERIDOL AND TRIHEXYPHENIDYL HYDROCHLORIDE IN TABLET DOSAGE FORM
A simple, fast and precise reversed phase-high performance liquid chromatographic (RP-HPLC) method is proposed for simultaneous determination of the binary mixture of haloperidol and tri- hexyphenidyl hydrochloride in pharmaceutical formulations. This method uses a mobile phase consisting of methanol:acetonitrile:water (50:40:10 v/v/v), Zodiac C18 column in isocratic mode, detection wavelength of 221 nm and a flow rate of 1.2 ml/minutes. The measured retention times for haloperidol and trihexyphenidyl hydrochloride are 6.12Â±0.02 and 8.06Â±0.02 minutes, respectively. The resolution of the two chromatographic peaks is 8.23. The validation of the method showed good linearity in the range 5-50 Î¼g/ml for haloperidol and in the range 2-20 Î¼g/ml for trihexyphenidyl hydrochloride. Further, satisfactory results are also established in terms of mean percent- age recovery (99.01-99.77% for haloperidol and 99.08-100.33% for trihexyphenidyl hydrochloride), intra-day and inter-day precision (<2%) and robustness. The advantages of this method are good resolution with sharper peaks and sufficient precision. This could be used for the determination of the above drugs in dosage forms in combination or individually and in bulk.
Froemming JS et al. Pharmacokinetics of haloperidol. Clinical Pharmacokinetics 1989; 17(6): 396-423.
Indian Pharmacopoeia, Vol. 1. New Delhi, The Controller of publication, Govt. of India. 2010; p1435.
British Pharmacopoeia, Vol. 1. London, The British Pharmacopoeia commission; 2012. online version.
Lea et al. Analysis of haloperidol tablets by high-performance liquid chromatography-an inter-laboratory study. J Chromatogr A 1982; 250: 35â€“42.
Imran Ali A, Hassan Y, Aboul-Enin B. Fast determination of haloperidol in pharmaceutical preparations using HPLC with monolithic silica column. Liquid chromatography 2005; 58: 3169-79.
Fang J, Gorrod JW. High-performance liquid chromatographic method for the detection and quantitation of haloperidol and seven of its metabolites in microsomal preparations. J Chromatogr B: Biomed Sci and Appl 1993; 614(2): 267â€“273.
Trabelsi et al. Determination and degradation study of haloperidol by high performance liquid chromatography. J Pharm Biomed Anal 2002; 29(4): 649â€“657.
Monser and Trablesi A. Rapid LC method for the determination of haloperidol and its degradation products in pharmaceuticals using a porous graphitic carbon column. J Liq Chromatogr & Related Tech 2003; 26(2): 267-271.
Xu et al. hplc analysis of haloperidol and its related compound in the drug substance and a tablet dosage form using a non-porous silica octadecylsilane column. J Liq chromatogr & Related Tech 1999; 22(12): 1857-1866.
Patela YP et al. A comparative study using HPLC and packed column supercritical fluid chromatography for the assay of three anti-psychotic dosage forms. Talanta 1998; 47 (3): 625â€“630.
Sane RT, Ghadge JK, Jain AB, Vaidya AT, Kotwal SS. RP-HPLC estimation of haloperidol and propantheline bromide in tablets or capsules. Indian Drugs 1992; 29: 240-4.
Silke Water et al. Quantification of the antipsychotics flupentixol and haloperidol in human serum by high - performance liquid chromatography with ultraviolet detection. J Chromatogr B: Biomed Sci and Appl 1998; 720(1-2): 231â€“237.
Arinobu T et al., Liquid chromatographicâ€“mass spectrometric determination of haloperidol and its metabolites in human plasma and urine. J Chromatogr B: Biomed Sci and Appl 2002; 776(1): 107â€“113.
Bargo E. Determination of trihexyphenidyl HCL dosage forms. J Pharm Sci 2006; 68(4):503-5.
Mahadik KR, Aggarwal H, Kaul N. RP-HPLC estimation of trihexyphenidyl HCL and chlorpromazine HCL in tablets. Indian Drugs 2002; 39: 441-5.
Capka, V et al., Stereoselective determination of trihexyphenidyl in human serum by LCâ€“ESIâ€“MS. J Pharm Biomed Anal 1999; 21(3): 507â€“517.
Desage, et al. Quantitation of trihexyphenidyl from plasma using a mass-selective detector and electron-impact ionization. J Chromatogr B: Biomed Sci and Appl 1991; 571(1-2): 250â€“256.
Wate SP, Borkar AA. Simultaneous spectrophotometric estimation of haloperidol and trihexyphenidyl HCL in tablets. Indian J Pharm Sci 2010; 72(2): 265-267.
Wate SP, Borkar AA. RP-HPLC estimation of haloperidol and trihexyphenidyl HCL in tablets. Intern J ChemTech Res 2009; 1(3): 675-676.
ICH Harmonized Tripartite Guideline Q2 (R1), Validation of analytical procedures: text and methodology. Current Step 4 Version, 2005.
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