Kalpesh N Patel, Umang H Gajjar, Paresh U Patel, Shyam Sunder Pancholi
Kalpesh N Patel1*, Umang H Gajjar2, Paresh U Patel3, Shyam Sunder Pancholi1
1Department of Pharmaceutical Chemistry and Quality Assurance, Ganpat University – Shree S. K. Patel College of Pharmaceutical Education and Research, Kherva, Mehsana, Gujarat, India - 384012.
2Department of Pharmacognosy, Ganpat University –
Shree S. K. Patel College of Pharmaceutical Education and Research, Kherva, Mehsana, Gujarat, India - 384012.
Volume - 12,
Issue - 4,
Year - 2022
Haloperidol is a common antipsychotic drug used to treat schizophrenia, and Trihexyphenidyl hydrochloride is an antiparkinsonian medication. The combination formulation is used to treat schizophrenia as well as depression. A simple, accurate, and precise assay as well as a rapid stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Haloperidol (HAL) and Trihexyphenidyl hydrochloride (THP) from their combination drug product have been developed and validated. The proposed method is based on reversed-phase separation of the two drugs using a Zorbax Eclipse XDB C18 column (150 mm x 4.6 mm, 5 um) kept at 30°C. The optimal mobile phase was composed of 0.5 mL triethylamine 0.05 M phosphate buffer having pH 3.75: acetonitrile: (65:35 v/v), a flow rate of 1.2 mL.min-1, and PDA detection at 210 nm. The method was validated in accordance with ICH standards. It was found to be precise and reproducible. Linearity was achieved in the concentration ranges of 6-60 ug mL-1 for HAL and 8-80 ug mL-1 for THP, with correlation coefficients of 0.999 and 1.000, respectively. The mean percent recovery of triplicate samples at each level for both drugs was 99.10-100.7% for Haloperidol and 98.7-100.6% for Trihexyphenidyl hydrochloride. The proposed method can be used to successfully test quality control and stability samples from bulk manufacturing and pharmaceutical dosage forms.
Cite this article:
Kalpesh N Patel, Umang H Gajjar, Paresh U Patel, Shyam Sunder Pancholi. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Haloperidol and Trihexyphenidyl Hydrochloride in Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022; 12(4):253-7. doi: 10.52711/2231-5675.2022.00041
Kalpesh N Patel, Umang H Gajjar, Paresh U Patel, Shyam Sunder Pancholi. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Haloperidol and Trihexyphenidyl Hydrochloride in Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022; 12(4):253-7. doi: 10.52711/2231-5675.2022.00041 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-4-6
1. Ratna VV, et al. Risk of cardiovascular disease in schizophrenia: A mini review. Asian J. Res. Pharm. Sci. 2019; 9(2):131-136.
2. Panchal II, et al. Schizophrenia: Treatment and Future aspects: a Systemic Review. Asian J. Res. Chem. 2012; 5(12): 1503-1512.
3. Mathew VK, et al. Epidemiology of schizophrenia in an indian hospital. Res. J. Pharm. and Tech. 2020; 13(1):219-223.
4. Kumar N, et al. Naringin exhibited anti-parkinsonian like effect against haloperidol-induced catalepsy in mice. Res. J. Pharm. and Tech. 2021; 14(2):662-666.
5. Tripathi KD. Essentials of medical pharmacology. 6th Edn, Jaypee publication, 2008, pp-421-422, 424-426.
6. Wiliam AP. Goodman and Gilman’s The Pharmacological basis of Therapeutics; 11th Edn, Tata Mac Graw Hill Publishing, 2007, pp-299-303, 344.
7. Rang HP, Dale MM and More KP. Text Book of Pharmacology. 6th Edn, Publishing elsevier, 2003, pp-548.
8. The Merck index. 14th Edn, Publish by merck research laboratories, division of merck & co., Whitehouse station, NJ, USA, 2006.pp 4602,9697.
9. Indian Pharmacopoeia, Vol. 1 New Delhi, The Controller of publication, Government of India 2010; p. 1435.
10. British Pharmacopoeia, Vol. 1 (online version). London, The British Pharmacopoeia commission; 2012.
11. The United State Pharmacopoeia, U.S. Pharmacopeial Convention, USP 30-NF 25, 2007, pp-2269-2270, 3413-3415.
12. Yasir M, Sara UV. Development of UV spectrophotometric method for the analysis of antipsychotic drug. Res. J. Pharm. and Tech. 2014; 7(6): 638-642.
13. Kawas G, et al. Spectrophotometric determination of haloperidol in pure form and pharmaceutical formulation using calcon and amido black. Res. J. Pharm. and Tech.2016; 9(2):139-144.
14. Rahman N, Khatoon A, Rahman H. Studies on the development of Spectrophotometric method for the determination of haloperidol in pharmaceutical preparations. Quim. Nova, 2012; 35(2): 392-397.
15. Kumar R, Agarwal A. Estimation of Haloperidol in Pharmaceutical Dosage Forms by UV-Spectrophotometer (April 11, 2020). Available at SSRN: https://ssrn.com/abstract=3573445 or http://dx.doi.org/10.2139/ssrn.3573445.
16. Lea AR, Hailey DM, Drugged PR. Analysis of haloperidol tablets by high-performance liquid chromatography-an interlaboratory study. J Chromatogr A. 1982; 250: 35–42.
17. Imran A, Hassan YA. Fast determination of haloperidol in pharmaceutical preparations using HPLC with a monolithic silica column. J Liq chromatogr and Rel. Tech. 2005; 28 Suppl 20: 3169-3179.
18. 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 Suppl 2: 267– 273.
19. Trabelsi H, et al. Determination and degradation study of haloperidol by high performance liquid chromatography. J Pharm Biomed Anal. 2002; 29 Suppl 4: 649–657.
20. Monser L, Trablesi H. A rapid LC method for the determination of haloperidol and its degradation products in pharmaceuticals using a porous graphitic carbon column. J Liq Chromatogr and Rel Tech. 2003; 26 Suppl 2: 267-271.
21. Xu X, Stewart JT. 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 and Rel Tech. 1999; 22 Suppl 12: 1857-1866.
22. Sane RT, et al. RP-HPLC estimation of haloperidol and propantheline bromide in tablets or capsules. Indian Drugs. 1992; 29: 240-244.
23. Water S, 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 Suppl 1-2: 231–237.
24. Jain A, et al. Comparison of RP-HPLC and UV spectrophotometric methods for estimation of haloperidol in pure and pharmaceutical formulation. JDDT [Internet]. 1Oct.2018 [cited 9Dec.2021]; 8(5):277-82. Available from: http://jddtonline.info/index.php/jddt/article/view/1973.
25. Seno H. Liquid chromatographic–mass spectrometric determination of haloperidol and its metabolites in human plasma and urine. J Chromatogr B: Biomed Sci and Appl. 2002; 776 Suppl 1: 107– 113.
26. Mahadik KR, Aggarwal H, Kaul N. RP-HPLC estimation of trihexyphenidyl HCl and chlorpromazine HCl in tablets. Indian Drugs. 2002; 39: 441-445.
27. Rajamanickam V, et al. Simultaneous determination of risperidone and trihexyphenidyl hydrochloride from bulk and tablet dosage form by RP-HPLC. Asian J. Res. Chem. 2010; 3(3): 549-551.
28. Patel A, et al. Method development and validation for estimation of trihexyphenidyl hydrochloride in tablet dosage forms. Asian J. Res. Chem. 2009; 2(2):104-107.
29. Capka V, Xu Y, Chen YH. Stereoselective determination of trihexyphenidyl in human serum by LC–ESI–MS. J Pharm Biomed Anal. 1999; 21 Suppl 3: 507.
30. Desage M, 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 Suppl 1-2: 250–256.
31. Wate SP, Borkar AA. Absorption Ratio Method for simultaneous estimation of haloperidol and trihexyphenidyl in tablet. Res J. Pharm. and Tech.2009;2(3): 603-604
32. Dammalapati S, Raju R. A RP-HPLC method for simultaneous determination of haloperidol and trihexyphenidyl hydrochloride in tablet dosage form. Asian J Pharm Clin Res. 2014, 7(2), 14-18.
33. Wate SP, Borkar AA. Simultaneous spectrophotometric estimation of haloperidol and trihexyphenidyl HCL in tablets. Ind J Pharm Sci. 2010; 72(2): 265-267.
34. Pudi R, Annapurna MM. New RP-UPLC method for the simultaneous determination of haloperidol and benzhexol in tablets. Res. J. Pharm. and Tech. 2019; 12(6): 2847 -2850.
35. The International Conference on Harmonization (ICH), Q2 (R1), Validation of Analytical Procedures: Text and Methodology, Q2B; 2005. Geneva, Switzerland.