High-Performance Liquid Chromatographic Assay for Ziprasidone hydrochloride in Bulk and Polymeric-Microspheres based Matrix Tablet
DOI:
https://doi.org/10.37285/ijpsn.2018.11.3.4Abstract
A significant percentage of psychiatric patients are treated with antipsychotic drug in the clinic. Thus, it is advantageous to use a rapid and reliable assay that is suitable for determination of antipsychotic drug in a single run. A simple and sensitive HPLC method was developed and validated for quantification of Ziprasidone hydrochloride (ZDH) and its polymeric microspheres-based matrix tablets. The chromatographic separation of ZDH was achieved on a C18 reverse-phase column (250 mm × 4.6 mm, 5µ, Enable) and a C18 guard column using acetonitrile-potassium dihydrogen phosphate buffer (pH 3.6 ± 0.1; 20.0 mM containing 0.2% v/v triethylamine) as a mobile phase in the ratio of 28:72%v/v at a flow rate of 1.0 mL/min which indicated a retention time within a short run time of 2 min. All the analytes were monitored using UV detection. The method was validated according to the International Conference on Harmonization guidelines Q2A and Q2B with respect to specificity, precision, linearity, accuracy, range, stability of analytical solution, robustness and system suitability. The LOQ was 20.0 ng/mL and correlation coefficient (R2) values for the linear range of 20.0-1000.0 ng/mL were 0.990 or greater for all the analytes. The satisfying recoveries (98.68-99.82%) and low relative standard deviation confirmed the suitability of the proposed method for the routine analysis of ZDH in bulk and its formulations.
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Keywords:
Ziprasidone hydrochloride, Matrix Tablet, HPLC system, Analytical method validation
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Published
2018-05-31
How to Cite
1.
Singh KNK, Kar M. High-Performance Liquid Chromatographic Assay for Ziprasidone hydrochloride in Bulk and Polymeric-Microspheres based Matrix Tablet. Scopus Indexed [Internet]. 2018 May 31 [cited 2024 Dec. 22];11(3):4105-11. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/370
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Research Articles
References
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Amperiadou A, and Georgarakis M (1995). Controlled release salbutamol sulphate microcapsules prepared by emulsion solvent-evaporation technique and study on the release affected parameters. Int J Pharm 115: 1-8.
Aravagiri M, Marder SR, and Pollock B (2007). Determination of Ziprasidone hydrochloride in human plasma by liquid chromatography-electrospray tandem mass spectrometry and its application to plasma level determination in schizophrenia patients. J Chromatograph B 847: 237-244.
Bressolle F, Bromet-Petit M, and Audran M (1996). Validation of liquid chromatographic and gas chromatographic methods. Applications to pharmacokinetics. J Chromatogr B Biomed Appl 686: 3-10.
Caley CF and Cooper CK (2002). Ziprasidone hydrochloride : The fifth atypical antipsychotic. Annals of Pharmacothera 36: 839-851.
Chaurasia S, Kulkarni GT, Shetty LN, and Pawar V (2011). Development and validation of UV spectroscopic method for the quick estimation of Piper betle leaf (PBL) extract. Int J Curr Pharm Res 3: 57-59.
Chow SC, and Shao J (2002). Statistics in Drug Research: Methodologies and Recent Developments, New York: Marcel Dekker Inc., 31-52.
Das SK, and Das NG (1998). Preparation and in vitro dissolution profile of dual polymer (Eudragit®RS100 and RL100) microparticles of diltiazem hydrochloride. J Microencapsulation 15: 445-452.
El-Sherif ZA, El-Zeany B, El-Houssini OM, Rashed MS, and Aboul-Enein HY (2004). Stability indicating reversed phase high performance liquid chromatographic and thin layer densitometric methods for the determination of Ziprasidone hydrochloride in bulk powder and in pharmaceutical formulations. Biomed Chromatograph 18: 143-149.
Janiszewski JS, Fouda HG, and Cole RO (1995). Development and validation of a high-sensitivity assay for an antipsychotic agent, CP-88,059, with solid-phase extraction and narrow-bore high performance liquid chromatography. J Chromatograph B 668: 133-139.
Kawata M, Nakamura M, Goto S, and Aoyama T (1986). Preparation and dissolution pattern of Eudragit RS microcapsules containing ketoprofen. Chem Pharm Bull 34: 2618-2623.
Kim CK, Kim MJ, and Oh KH (1994). Preparation and evaluation of sustained release microspheres of terbutaline sulfate. Int J Pharm 106: 213-219.
Kul D, Gumustas M, Uslu B, and Ozkan SA (2010). Electroanalytical characteristics of antipsychotic drug Ziprasidone hydrochloride and its determination in pharmaceuticals and serum samples on solid electrodes. Talanta 82: 286-295.
Mateovic T, Kriznar B, Bogataj M, and Mrhar A (2002). The influence of stirring rate on biopharmaceutical properties of Eudragit RS microspheres. J Microencapsulation 19: 29-36.
Miceli JJ, Wilner KD, Hansen RA, Johnson AC, Apseloff G, and Gerber N (2000). Single- and multiple-dose pharmacokinetics of Ziprasidone hydrochloride under non-fasting conditions in healthy male volunteers. British J Clin Pharmacol 49: 5-13.
Pignatello R, Consoli P, and Puglisi G (2000). In vitro release kinetics of Tolmetin from tabletted Eudragit microparticles. J Microencapsulation 17: 373-383.
Sachse J, Hartter S, and Hiemke C (2005). Automated determination of Ziprasidone hydrochloride by HPLC with column switching and spectrophotometric detection. Therap Drug Monitoring 27: 158-162.
Schmidt AW, Lebel LA, Howard HR Jr, and Zorn SH (2001). Ziprasidone hydrochloride : A novel antipsychotic agent with a unique human receptor binding profile. Euro J Pharmacol 425: 197-201.
Seeger TF, Seymour PA, Schmidt AW, Zorn SH, Schulz DW, Lebel LA, McLean S, Guanowsky V, Howard HR, and Lowe JA 3rd (1995). Ziprasidone hydrochloride (CP-88,059): A new antipsychotic with combined dopamine and serotonin receptor antagonist activity. J Pharmacol Experiment Therap 275: 101-113.
Sengel CT, Hascicek C, and Gonul N (2006). Development and in-vitro evaluation of modified release tablets including ethyl cellulose microspheres loaded with diltiazem hydrochloride. J Microencap 23: 135-152.
Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, and McDowall RD (1992). Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies, Conference report, Int J Pharm 82: 1-7.
Singh A, Rao BM, Deshpande GR, Sangaraju S, Lalithadevi M, Satyanarayana, P.V.V. et al. (2007). A Rapid Stability-indicating LC Method for Ziprasidone hydrochloride. Chromatographia, 65: 191-196.
Suckowa RF, Fein M, Correll CU, and Cooper TB (2004). Determination of plasma Ziprasidone hydrochloride using liquid chromatography with fluorescence detection. J Chromatograph B 799: 201-208.
Wilner KD, Demattos SB, Anziano RJ, Apseloff G and Gerber N (2000). Ziprasidone hydrochloride and the activity of cytochrome P450 2D6 in healthy extensive metabolizers. British J Clin Pharmacol 49: 43S-47S.
Wilner KD, Tensfeldt TG, Baris B, Smolarek TA, Turncliff RZ, Colburn WA, and Hansen RA (2000). Single- and multiple-dose pharmacokinetics of Ziprasidone hydrochloride in healthy young and elderly volunteers. British J Clin Pharmacol 49: 15-20.
Zhang G, Terry AV Jr, and Bartlett MG (2007). Simultaneous estimation of five antipsychotic drugs in rat plasma by high performance liquid chromatography with ultraviolet detection. J Chromatograph B 856: 20-28.
Zhang G, Terry AV Jr, and Bartlett MG (2008). Determination of the lipophilic antipsychotic drug Ziprasidone hydrochloride in rat plasma and brain tissue using liquid chromatography-tandem mass spectrometry. Biomed Chromatograph 22: 770-778
Amperiadou A, and Georgarakis M (1995). Controlled release salbutamol sulphate microcapsules prepared by emulsion solvent-evaporation technique and study on the release affected parameters. Int J Pharm 115: 1-8.
Aravagiri M, Marder SR, and Pollock B (2007). Determination of Ziprasidone hydrochloride in human plasma by liquid chromatography-electrospray tandem mass spectrometry and its application to plasma level determination in schizophrenia patients. J Chromatograph B 847: 237-244.
Bressolle F, Bromet-Petit M, and Audran M (1996). Validation of liquid chromatographic and gas chromatographic methods. Applications to pharmacokinetics. J Chromatogr B Biomed Appl 686: 3-10.
Caley CF and Cooper CK (2002). Ziprasidone hydrochloride : The fifth atypical antipsychotic. Annals of Pharmacothera 36: 839-851.
Chaurasia S, Kulkarni GT, Shetty LN, and Pawar V (2011). Development and validation of UV spectroscopic method for the quick estimation of Piper betle leaf (PBL) extract. Int J Curr Pharm Res 3: 57-59.
Chow SC, and Shao J (2002). Statistics in Drug Research: Methodologies and Recent Developments, New York: Marcel Dekker Inc., 31-52.
Das SK, and Das NG (1998). Preparation and in vitro dissolution profile of dual polymer (Eudragit®RS100 and RL100) microparticles of diltiazem hydrochloride. J Microencapsulation 15: 445-452.
El-Sherif ZA, El-Zeany B, El-Houssini OM, Rashed MS, and Aboul-Enein HY (2004). Stability indicating reversed phase high performance liquid chromatographic and thin layer densitometric methods for the determination of Ziprasidone hydrochloride in bulk powder and in pharmaceutical formulations. Biomed Chromatograph 18: 143-149.
Janiszewski JS, Fouda HG, and Cole RO (1995). Development and validation of a high-sensitivity assay for an antipsychotic agent, CP-88,059, with solid-phase extraction and narrow-bore high performance liquid chromatography. J Chromatograph B 668: 133-139.
Kawata M, Nakamura M, Goto S, and Aoyama T (1986). Preparation and dissolution pattern of Eudragit RS microcapsules containing ketoprofen. Chem Pharm Bull 34: 2618-2623.
Kim CK, Kim MJ, and Oh KH (1994). Preparation and evaluation of sustained release microspheres of terbutaline sulfate. Int J Pharm 106: 213-219.
Kul D, Gumustas M, Uslu B, and Ozkan SA (2010). Electroanalytical characteristics of antipsychotic drug Ziprasidone hydrochloride and its determination in pharmaceuticals and serum samples on solid electrodes. Talanta 82: 286-295.
Mateovic T, Kriznar B, Bogataj M, and Mrhar A (2002). The influence of stirring rate on biopharmaceutical properties of Eudragit RS microspheres. J Microencapsulation 19: 29-36.
Miceli JJ, Wilner KD, Hansen RA, Johnson AC, Apseloff G, and Gerber N (2000). Single- and multiple-dose pharmacokinetics of Ziprasidone hydrochloride under non-fasting conditions in healthy male volunteers. British J Clin Pharmacol 49: 5-13.
Pignatello R, Consoli P, and Puglisi G (2000). In vitro release kinetics of Tolmetin from tabletted Eudragit microparticles. J Microencapsulation 17: 373-383.
Sachse J, Hartter S, and Hiemke C (2005). Automated determination of Ziprasidone hydrochloride by HPLC with column switching and spectrophotometric detection. Therap Drug Monitoring 27: 158-162.
Schmidt AW, Lebel LA, Howard HR Jr, and Zorn SH (2001). Ziprasidone hydrochloride : A novel antipsychotic agent with a unique human receptor binding profile. Euro J Pharmacol 425: 197-201.
Seeger TF, Seymour PA, Schmidt AW, Zorn SH, Schulz DW, Lebel LA, McLean S, Guanowsky V, Howard HR, and Lowe JA 3rd (1995). Ziprasidone hydrochloride (CP-88,059): A new antipsychotic with combined dopamine and serotonin receptor antagonist activity. J Pharmacol Experiment Therap 275: 101-113.
Sengel CT, Hascicek C, and Gonul N (2006). Development and in-vitro evaluation of modified release tablets including ethyl cellulose microspheres loaded with diltiazem hydrochloride. J Microencap 23: 135-152.
Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, and McDowall RD (1992). Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies, Conference report, Int J Pharm 82: 1-7.
Singh A, Rao BM, Deshpande GR, Sangaraju S, Lalithadevi M, Satyanarayana, P.V.V. et al. (2007). A Rapid Stability-indicating LC Method for Ziprasidone hydrochloride. Chromatographia, 65: 191-196.
Suckowa RF, Fein M, Correll CU, and Cooper TB (2004). Determination of plasma Ziprasidone hydrochloride using liquid chromatography with fluorescence detection. J Chromatograph B 799: 201-208.
Wilner KD, Demattos SB, Anziano RJ, Apseloff G and Gerber N (2000). Ziprasidone hydrochloride and the activity of cytochrome P450 2D6 in healthy extensive metabolizers. British J Clin Pharmacol 49: 43S-47S.
Wilner KD, Tensfeldt TG, Baris B, Smolarek TA, Turncliff RZ, Colburn WA, and Hansen RA (2000). Single- and multiple-dose pharmacokinetics of Ziprasidone hydrochloride in healthy young and elderly volunteers. British J Clin Pharmacol 49: 15-20.
Zhang G, Terry AV Jr, and Bartlett MG (2007). Simultaneous estimation of five antipsychotic drugs in rat plasma by high performance liquid chromatography with ultraviolet detection. J Chromatograph B 856: 20-28.
Zhang G, Terry AV Jr, and Bartlett MG (2008). Determination of the lipophilic antipsychotic drug Ziprasidone hydrochloride in rat plasma and brain tissue using liquid chromatography-tandem mass spectrometry. Biomed Chromatograph 22: 770-778
