A NOVEL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TRIFLUOPERAZINE AND ISOPROPAMIDE IN TABLET DOSAGE FORM
Abstract
The present paper describes a reverse phase HPLC method for simultaneous estimation of Trifluoperazine and Isopropamide from their combined tablet dosage form. The proposed RP-HPLC method utilizes an Agilent Zorbax, C18 column (250 × 4.6 mm, 5μm particle size) using a mobile phase consisting of mixture of Buffer: Acetonitrile (80: 20 v/v) mobile phase flow rate of 0.8 ml/min; and UV detection at 227nm. The retention time for Trifluoperazine and Isopropamide were 2.4 and 3.62 minutes respectively. The method was linear in the range of 40-120μg/ml and 100-300μg/ml and correlation coefficients were 1.00 and 1.00 for Trifluoperazine and Isopropamide respectively. The limit of detection was found to be 2.963 and 2.985µg/ml for Trifluoperazine and Isopropamide respectively. Limit of quantification was found to be 9.877 and 9.9502 for Trifluoperazine and Isopropamide respectively. The percentage recoveries for Trifluoperazine and Isopropamide ranged from 100.03-100.36% and 100.00-100.07 % respectively. The percentage of RSD for precision of the method was found to be less than 2%. The proposed method can be used for the routine analysis for the estimation of these drugs in combined dosage form.
Keywords:
Trifluoperazine, Isopropamide, RP-HPLC, ValidationDOI
https://doi.org/10.25004/IJPSDR.2015.070119References
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15. Hassib ST, El-Kousy NM, Alian Al-Shimaa M. Three reversed phase liquid chromatographic methods for the determination of some anticholenergic drugs in the presence of their degradation products and / or in mixture with other drugs. Bull. Pharm. Sci. 2011; 34(2):131-140.
16. Javaid JI, Dekirmenjian H, Davis JM. GLC analysis of Trifluoperazine in human plasma. Journal of Pharmaceutical Sciences 2012; 71:63-66.
17. Turabi ZM, Khatatbeh OA, Al-Abed DN. RP-HPLC method development and validation for the simultaneous determination of mebendazole and the two preservatives methylparaben and propylparaben in pharmaceutical oral suspension dosage form. International Journal of Pharmaceutical Sciences and Drug Research 2014; 6(1):70-74.
18. Rasheed A, Pattanayak S, Rama Rao T. Analytical method development and validation for the simultaneous estimation of aspirin, clopidogrel bisulphate and atorvastatin calcium in tablet dosage form. Am. J. PharmTech Res. 2014; 4:534-541.
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2. United States Pharmacopoeia. National Formulary USP30, Arabswell Edition, Inc., 2000, pp. 926, 1703.
3. Sharma MC, Sharma S. Development and Validation of Method for Simultaneous Estimation of Trifluoperazine hydrochloride from Capsule Dosage Form Using Citric Acid. World Journal of Chemistry 2011; 6:80-84.
4. Watson JR, Fumi M, French WN. Trifluoperazine tablets, Alternative methods of analysis. J. Pharmac. Sci. 1997; 59:391-394.
5. El-Gindy A, El-Zeany B, Awad T, Shabana MM. Spectrophotometric determination of Trifluoperazine HCl and Isopropamide iodide in binary mixture using second derivative and second derivative of the ratio spectra methods. J. Pharm. Biomed. Anal. 2001; 26:203-10.
6. Laassis B, Maafi M, Aaron JJ, Mahedero MC. Fluorimetric and photochemically induced fluorimetric determination of ethopropazine, levomepromazine, thioproperazine and Trifluoperazine. J. Analytical Lett. 1997; 30:1541-54.
7. Perez-Ruiz T, Martinez-Lozano C, Tomas V, Sidrach DE, Cardona C. Flow-injection fluorimetric determination of trimeprazine and trifluoperazine in pharmaceutical preparations. Talanta. 1993; 40:1361-65.
8. El-Gindy A, El-Zeany B, Awad T, Shabana MM. Derivative Spectrophotometric, thin layer chromatographic densitometric and high performance liquid chromatographic determination of Trifluoperazine hydrochloride in presence of its hydrogen peroxide induced degradation product. J. Pharm. Biomed. Anal. 2002; 27:9-18.
9. Midha KK, Roscoe RMH, Hall K, Hawes EM. A gas chromatographic mass spectrometric assay for plasma Trifluoperazine concentrations following single doses. Biological Mass Spectroscopy 2001; 9:186-190.
10. Mahadik KR, Aggarwal H, Kaul N. Simultaneous HPTLC estimation of trifluoperazine HCL, trihexyphenidyl HCL and chlorpromazine HCL in tablet dosage form. J. Indian Drugs. 2003; 40:340-341.
11. Pradas TN, Sivakumar M. HPLC quantification of a tri-component psychiatric formulation containing chlorpromazine, trifluoperazine and trihexyphenidyl. J. Pharmazie. 1992; 47:231.
12. Laassis B, Maafi M, Aaron J J, Mahedero MC. Fluorimetric and photochemically induced fluorimetric determination of ethopropazine, levomepromazine, thioproperazine and trifluoperazine. J. Analytical letters. 1997; 30:1541-54.
13. Hassib ST, Moussa BA, Hashim HA, El-Zaher AA. Determination of certain antispasmodic drugs as single ingredient, mebeverine hydrochloride, and in two component mixtures, mebeverine hydrochloride-sulpiride and isopropamide iodide-trifluoperazine hydrochloride. IBID. 2002; 35:43.
14. Abd-El-Hamid NA. Simultaneous determination of phenylpropanolamine hydrochloride and isopropamide in capsule by HPLC using Crownpak column. Anal Lett. 1993; 26:1153.
15. Hassib ST, El-Kousy NM, Alian Al-Shimaa M. Three reversed phase liquid chromatographic methods for the determination of some anticholenergic drugs in the presence of their degradation products and / or in mixture with other drugs. Bull. Pharm. Sci. 2011; 34(2):131-140.
16. Javaid JI, Dekirmenjian H, Davis JM. GLC analysis of Trifluoperazine in human plasma. Journal of Pharmaceutical Sciences 2012; 71:63-66.
17. Turabi ZM, Khatatbeh OA, Al-Abed DN. RP-HPLC method development and validation for the simultaneous determination of mebendazole and the two preservatives methylparaben and propylparaben in pharmaceutical oral suspension dosage form. International Journal of Pharmaceutical Sciences and Drug Research 2014; 6(1):70-74.
18. Rasheed A, Pattanayak S, Rama Rao T. Analytical method development and validation for the simultaneous estimation of aspirin, clopidogrel bisulphate and atorvastatin calcium in tablet dosage form. Am. J. PharmTech Res. 2014; 4:534-541.
19. ICH, Q2 (R1) Validation of Analytical Procedures: text and methodology, 2005.
20. Code Q2A-Text on Validation of Analytical Procedure Step-3 Consensus Guideline, 1994, ICH Harmonised Tripartite Guideline.
21. Code Q2B-Validation of Analytical Procedures Methodology Step-4 Consensus Guideline, 1994, ICH Harmonised Tripartite Guideline.
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01-01-2015
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“A NOVEL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TRIFLUOPERAZINE AND ISOPROPAMIDE IN TABLET DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 1, Jan. 2015, pp. 105-9, https://doi.org/10.25004/IJPSDR.2015.070119.
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How to Cite
“A NOVEL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TRIFLUOPERAZINE AND ISOPROPAMIDE IN TABLET DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 1, Jan. 2015, pp. 105-9, https://doi.org/10.25004/IJPSDR.2015.070119.
