ESTIMATION OF SODIUM VALPROATE IN TABLET DOSAGE FORM BY RP-HPLC WITHOUT PRIOR DERIVATIZATION: APPLICATION TO DISSOLUTION STUDIES
Abstract
A simple, precise and reproducible reverse phase, isocratic high performance liquid chromatographic method was developed and validated for the quantitative determination of sodium valproate in bulk and enteric coated tablet dosage form. The quantification was carried out using a Nova-pack phenyl, 4µm, 150 mm × 3.9 mm i.d. column, with a mobile phase consisting of acetonitrile: buffer (30:70, v/v) (pH 2.5) at a flow rate of 1.2 ml/min and UV detection at 210 nm. The method was validated for specificity, linearity, accuracy, precision, limit of detection, limit of quantification, robustness and solution stability. The linearity of the proposed method was investigated in the range of 50-1500 µg/ml (r = 0.9999). Mean inter- and intra-assay relative standard deviations (RSD) were less than 2.0 %. The proposed method was successfully applied for the analysis of sodium valproate in bulk and pharmaceutical dosage forms. Also, the method was extended for determination of sodium valproate release from in-vitro dissolution studies.
Keywords:
Sodium valproate; Dissolution; Reversed-phase; HPLC; Dosage forms.DOI
https://doi.org/10.25004/IJPSDR.2009.010210References
1. Willmore LJ. Psychopharmacology 2003; 37: 43.
2. Deepak S J, Gunta S, Mallika S, Pranav S. A high throughput and selective method for the estimation of Valproic acid an antiepileptic drug in human plasma by tandem LC-MS/MS. Talanta 2007; 72(1): 80-88.
3. Tsukasa M, Masaharu N, Hiroyuki W, Susumu Y, Kenji S. Determination of Valproic acid in serum by Liquid Chromatography-Atmospheric Pressure Chemical Ionization Mass Spectrometry. Anal sci 2007; 17: 999.
4. Amini H, Javan M, Ahmadiani A. Development and validation of a sensitive assay of Valproic acid in human plasma by high-performance liquid chromatography without prior derivatization. J. Chromatogr. B Analyt Technol Biomed Life Sci 2006; 830(2): 368-71.
5. Kishore P, Rajani K V, Satyanarayana V, Krishna D R. HPLC determination of valproic acid in human serum. Phammazie 2003; 58(6): 378-80.
6. Lucarelli C, Villa P, Lombaradi E, Prandini P, Brega A. HPLC method for Simultaneous analysis of valproic acid and other common anticonvulsant drugs in human plasma or serum. Chromatographia 1992; 33: 37-40.
7. Gentile de Illiano B and Quintana de Gainzarain A. HPLC determination of valproic acid in human plasma by derivatization with O-p-nitrobenzyl-N, N-diisopropylisourea. Journal of high resolution chromatography 1989; 12(8): 540-543.
8. Kazuko K, Mikio N, Ryota N, Satoshi K. Direct method for determination of Valproic Acid in Serum by High Performance Liquid Chromatography. Anal sci 1985; 1: 385.
9. Yan Z, Zheng J Yunqiu Y. Simultaneous determination of mycophenolic acid and Valproic acid based on derivatization by high-performance liquid chromatography with fluorescence detection.Biomed Chromatogr 2006; 20: 319–326.
10. Shuuji H, Motoki K, Kazuo I, Misa F, Nobufumi O, Takeshi K. Determination of Valproic acid in human serum by High Performance Liquid Chromatography with Fluorescence detection. Biol Pharm Bull 1999; 22(9): 975.
11. Liu H, Forman L J, Montoya J, Eggers C, Barham C, Delgado M. Determination of valproic acid by high performance liquid chromatography with photodiode-array and fluorescence detection. Journal of chromatography: Biomedical applications 1992; 576(1): 163-169.
12. Masaharu N, Akira S, Kenji S. Determination of serum valproate by high performance liquid chromatography using fluorescence labeling with 9-ammophenanthrene. Anal sci 1988; 4: 385- 388.
13. Susanto F, Reinauer H. Determination of Valproic Acid in Serum by isotop-dilution mass spectrometry. Chromatographia 1995; 41: 407- 413.
14. Riva R, Albani F, Baruzzi A. Rapid and simple GLC determination of Valproic acid and Ethosuximide in plasma of epileptic patients. J pharm sci 1982; 71(1): 110.
15. Krogh M, Johansen K, Tonnesen F, Rasmussen KE. Solid-Phase microextraction for the determination of the free concentration of Valproic acid in human plasma by capillary gas chromatography. Journal of chromatography B: Biomedical science and applications 1995; 673(2): 299- 305.
16. Pravin S, Abdorreza M, Naader A. Determination of the Valproic acid in human serum and pharmaceutical preparation by headspace liquid phase microextraction gas chromatography flame ionization detection without prior derivatization. J chromatogr B 2006; 850: 128-133.
17. Crowther JB. Validation of pharmaceutical test methods. In: Handbook of modern pharmaceutical analysis, Academic press, New York, 2001, pp. 415–443.
2. Deepak S J, Gunta S, Mallika S, Pranav S. A high throughput and selective method for the estimation of Valproic acid an antiepileptic drug in human plasma by tandem LC-MS/MS. Talanta 2007; 72(1): 80-88.
3. Tsukasa M, Masaharu N, Hiroyuki W, Susumu Y, Kenji S. Determination of Valproic acid in serum by Liquid Chromatography-Atmospheric Pressure Chemical Ionization Mass Spectrometry. Anal sci 2007; 17: 999.
4. Amini H, Javan M, Ahmadiani A. Development and validation of a sensitive assay of Valproic acid in human plasma by high-performance liquid chromatography without prior derivatization. J. Chromatogr. B Analyt Technol Biomed Life Sci 2006; 830(2): 368-71.
5. Kishore P, Rajani K V, Satyanarayana V, Krishna D R. HPLC determination of valproic acid in human serum. Phammazie 2003; 58(6): 378-80.
6. Lucarelli C, Villa P, Lombaradi E, Prandini P, Brega A. HPLC method for Simultaneous analysis of valproic acid and other common anticonvulsant drugs in human plasma or serum. Chromatographia 1992; 33: 37-40.
7. Gentile de Illiano B and Quintana de Gainzarain A. HPLC determination of valproic acid in human plasma by derivatization with O-p-nitrobenzyl-N, N-diisopropylisourea. Journal of high resolution chromatography 1989; 12(8): 540-543.
8. Kazuko K, Mikio N, Ryota N, Satoshi K. Direct method for determination of Valproic Acid in Serum by High Performance Liquid Chromatography. Anal sci 1985; 1: 385.
9. Yan Z, Zheng J Yunqiu Y. Simultaneous determination of mycophenolic acid and Valproic acid based on derivatization by high-performance liquid chromatography with fluorescence detection.Biomed Chromatogr 2006; 20: 319–326.
10. Shuuji H, Motoki K, Kazuo I, Misa F, Nobufumi O, Takeshi K. Determination of Valproic acid in human serum by High Performance Liquid Chromatography with Fluorescence detection. Biol Pharm Bull 1999; 22(9): 975.
11. Liu H, Forman L J, Montoya J, Eggers C, Barham C, Delgado M. Determination of valproic acid by high performance liquid chromatography with photodiode-array and fluorescence detection. Journal of chromatography: Biomedical applications 1992; 576(1): 163-169.
12. Masaharu N, Akira S, Kenji S. Determination of serum valproate by high performance liquid chromatography using fluorescence labeling with 9-ammophenanthrene. Anal sci 1988; 4: 385- 388.
13. Susanto F, Reinauer H. Determination of Valproic Acid in Serum by isotop-dilution mass spectrometry. Chromatographia 1995; 41: 407- 413.
14. Riva R, Albani F, Baruzzi A. Rapid and simple GLC determination of Valproic acid and Ethosuximide in plasma of epileptic patients. J pharm sci 1982; 71(1): 110.
15. Krogh M, Johansen K, Tonnesen F, Rasmussen KE. Solid-Phase microextraction for the determination of the free concentration of Valproic acid in human plasma by capillary gas chromatography. Journal of chromatography B: Biomedical science and applications 1995; 673(2): 299- 305.
16. Pravin S, Abdorreza M, Naader A. Determination of the Valproic acid in human serum and pharmaceutical preparation by headspace liquid phase microextraction gas chromatography flame ionization detection without prior derivatization. J chromatogr B 2006; 850: 128-133.
17. Crowther JB. Validation of pharmaceutical test methods. In: Handbook of modern pharmaceutical analysis, Academic press, New York, 2001, pp. 415–443.
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01-07-2009
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“ESTIMATION OF SODIUM VALPROATE IN TABLET DOSAGE FORM BY RP-HPLC WITHOUT PRIOR DERIVATIZATION: APPLICATION TO DISSOLUTION STUDIES”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 1, no. 2, July 2009, pp. 103-6, https://doi.org/10.25004/IJPSDR.2009.010210.
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How to Cite
“ESTIMATION OF SODIUM VALPROATE IN TABLET DOSAGE FORM BY RP-HPLC WITHOUT PRIOR DERIVATIZATION: APPLICATION TO DISSOLUTION STUDIES”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 1, no. 2, July 2009, pp. 103-6, https://doi.org/10.25004/IJPSDR.2009.010210.
