Stability-indicating HPTLC determination of imatinib mesylate in bulk drug and pharmaceutical dosage form

N. Vadera, G. Subramanian, P. Musmade

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of imatinib mesylate both as a bulk drug and in formulations was developed and validated. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of chloroform:methanol (6:4, v/v). The system was found to give compact spot for imatinib mesylate (Rf value of 0.53 ± 0.02). Densitometric analysis of imatinib mesylate was carried out in the absorbance mode at 276 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9966 ± 0.0013 with respect to peak area in the concentration range 100-1000 ng per spot. The mean value ± S.D. of slope and intercept were 164.85 ± 0.72 and 1168.3 ± 8.26 with respect to peak area. The method was validated for precision, recovery and robustness. The limits of detection and quantitation were 10 and 30 ng per spot, respectively. Imatinib mesylate was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and heat conditions. This indicates that the drug is susceptible to acid, base hydrolysis, oxidation and heat. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of said drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of imatinib mesylate in bulk drug and dosage forms. © 2006 Elsevier B.V. All rights reserved.
Original languageEnglish
Pages (from-to)722-726
Number of pages5
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume43
Issue number2
DOIs
Publication statusPublished - 2007
Externally publishedYes

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Dosage Forms
Pharmaceutical Preparations
Hot Temperature
Oxidation
Hydrolysis
Drug Compounding
Acids
Silica Gel
Alkalies
Thin Layer Chromatography
Chloroform
Aluminum
Linear regression
Regression analysis
Calibration
Methanol
Limit of Detection
Linear Models
Statistical methods
Pyrolysis

Cite this

@article{120043abf1104a6f97ed1f2ea3753078,
title = "Stability-indicating HPTLC determination of imatinib mesylate in bulk drug and pharmaceutical dosage form",
abstract = "A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of imatinib mesylate both as a bulk drug and in formulations was developed and validated. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of chloroform:methanol (6:4, v/v). The system was found to give compact spot for imatinib mesylate (Rf value of 0.53 ± 0.02). Densitometric analysis of imatinib mesylate was carried out in the absorbance mode at 276 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9966 ± 0.0013 with respect to peak area in the concentration range 100-1000 ng per spot. The mean value ± S.D. of slope and intercept were 164.85 ± 0.72 and 1168.3 ± 8.26 with respect to peak area. The method was validated for precision, recovery and robustness. The limits of detection and quantitation were 10 and 30 ng per spot, respectively. Imatinib mesylate was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and heat conditions. This indicates that the drug is susceptible to acid, base hydrolysis, oxidation and heat. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of said drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of imatinib mesylate in bulk drug and dosage forms. {\circledC} 2006 Elsevier B.V. All rights reserved.",
author = "N. Vadera and G. Subramanian and P. Musmade",
note = "Cited By :21 Export Date: 10 November 2017 CODEN: JPBAD Correspondence Address: Subramanian, G.; Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka 576104, India; email: g.subbu@manipal.edu Chemicals/CAS: imatinib, 152459-95-5, 220127-57-1; Antineoplastic Agents; Capsules; Chloroform, 67-66-3; imatinib, 152459-95-5; Methanol, 67-56-1; Piperazines; Powders; Protein Kinase Inhibitors; Pyrimidines; Silicon Dioxide, 7631-86-9; silochrome, 60650-90-0; Solvents Tradenames: Linomat IV, Camag, Switzerland; TLC scanner III, Camag Manufacturers: Natco, IndiaCamag, Switzerland References: Maki, R.G., (2004) Curr. Treat. Options Gastroenterol., 7, pp. 13-17; Adcock, I.M., Chung, K.F., Caramori, G., Ito, K., (2006) Eur. J. Pharmacol., 533, pp. 118-132; Vivekanand, V.V., Rao, S., Vaidyanathan, G., Sekher, N.M., Kelkar, S.A., Puranik, P.R., (2003) J. Pharm. Biomed. Anal., 33, pp. 879-889; Velapandian, T., Mathur, R., Agarwal, N.K., Arora, B., Kumar, L., Gupta, S.K., (2004) J. Chromatogr. B, 804, pp. 431-434; Bakhtiar, R., Khemani, L., Hayes, M., Bedman, T., Tse, F., (2002) J. Pharm. Biomed. Anal., 28, pp. 1183-1194; Parise, R.A., Ramanathan, R.K., Hayes, M.J., Egorin, M.J., (2003) J. Chromatogr. B: Anal. Technol. Biomed. Life Sci., 79, pp. 39-44; ICH, (1993) International Conference on Harmonization, , Geneva, October; Sethi, P.D., (1996) High Performance Thin Layer Chromatography, Quantitative Analysis of Pharmaceutical Formulations, , CBS Publishers; Kulkarni, S.P., Amin, P.D., (2000) J. Pharm. Biomed. Anal., 23, pp. 983-987; Thoppil, S.O., Cardoza, R.M., Amin, P.D., (2001) J. Pharm. Biomed. Anal., 25, pp. 15-20; Makhija, S.N., Vavia, P.R., (2001) J. Pharm. Biomed. Anal., 25, pp. 663-667; Ivanovic, D., Medenica, M., Jancic, B., Malenovic, A., (2004) J. Chromatogr. B, 800, pp. 253-258; ICH, (1994) Proceedings of the International Conference on Harmonization, , Geneva, October; Bakshi, M., Singh, S., (2002) J. Pharm. Biomed. Anal., 28, pp. 1011-1040",
year = "2007",
doi = "10.1016/j.jpba.2006.07.022",
language = "English",
volume = "43",
pages = "722--726",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
issn = "0731-7085",
publisher = "Elsevier",
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}

Stability-indicating HPTLC determination of imatinib mesylate in bulk drug and pharmaceutical dosage form. / Vadera, N.; Subramanian, G.; Musmade, P.

In: Journal of Pharmaceutical and Biomedical Analysis, Vol. 43, No. 2, 2007, p. 722-726.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Stability-indicating HPTLC determination of imatinib mesylate in bulk drug and pharmaceutical dosage form

AU - Vadera, N.

AU - Subramanian, G.

AU - Musmade, P.

N1 - Cited By :21 Export Date: 10 November 2017 CODEN: JPBAD Correspondence Address: Subramanian, G.; Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka 576104, India; email: g.subbu@manipal.edu Chemicals/CAS: imatinib, 152459-95-5, 220127-57-1; Antineoplastic Agents; Capsules; Chloroform, 67-66-3; imatinib, 152459-95-5; Methanol, 67-56-1; Piperazines; Powders; Protein Kinase Inhibitors; Pyrimidines; Silicon Dioxide, 7631-86-9; silochrome, 60650-90-0; Solvents Tradenames: Linomat IV, Camag, Switzerland; TLC scanner III, Camag Manufacturers: Natco, IndiaCamag, Switzerland References: Maki, R.G., (2004) Curr. Treat. Options Gastroenterol., 7, pp. 13-17; Adcock, I.M., Chung, K.F., Caramori, G., Ito, K., (2006) Eur. J. Pharmacol., 533, pp. 118-132; Vivekanand, V.V., Rao, S., Vaidyanathan, G., Sekher, N.M., Kelkar, S.A., Puranik, P.R., (2003) J. Pharm. Biomed. Anal., 33, pp. 879-889; Velapandian, T., Mathur, R., Agarwal, N.K., Arora, B., Kumar, L., Gupta, S.K., (2004) J. Chromatogr. B, 804, pp. 431-434; Bakhtiar, R., Khemani, L., Hayes, M., Bedman, T., Tse, F., (2002) J. Pharm. Biomed. Anal., 28, pp. 1183-1194; Parise, R.A., Ramanathan, R.K., Hayes, M.J., Egorin, M.J., (2003) J. Chromatogr. B: Anal. Technol. Biomed. Life Sci., 79, pp. 39-44; ICH, (1993) International Conference on Harmonization, , Geneva, October; Sethi, P.D., (1996) High Performance Thin Layer Chromatography, Quantitative Analysis of Pharmaceutical Formulations, , CBS Publishers; Kulkarni, S.P., Amin, P.D., (2000) J. Pharm. Biomed. Anal., 23, pp. 983-987; Thoppil, S.O., Cardoza, R.M., Amin, P.D., (2001) J. Pharm. Biomed. Anal., 25, pp. 15-20; Makhija, S.N., Vavia, P.R., (2001) J. Pharm. Biomed. Anal., 25, pp. 663-667; Ivanovic, D., Medenica, M., Jancic, B., Malenovic, A., (2004) J. Chromatogr. B, 800, pp. 253-258; ICH, (1994) Proceedings of the International Conference on Harmonization, , Geneva, October; Bakshi, M., Singh, S., (2002) J. Pharm. Biomed. Anal., 28, pp. 1011-1040

PY - 2007

Y1 - 2007

N2 - A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of imatinib mesylate both as a bulk drug and in formulations was developed and validated. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of chloroform:methanol (6:4, v/v). The system was found to give compact spot for imatinib mesylate (Rf value of 0.53 ± 0.02). Densitometric analysis of imatinib mesylate was carried out in the absorbance mode at 276 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9966 ± 0.0013 with respect to peak area in the concentration range 100-1000 ng per spot. The mean value ± S.D. of slope and intercept were 164.85 ± 0.72 and 1168.3 ± 8.26 with respect to peak area. The method was validated for precision, recovery and robustness. The limits of detection and quantitation were 10 and 30 ng per spot, respectively. Imatinib mesylate was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and heat conditions. This indicates that the drug is susceptible to acid, base hydrolysis, oxidation and heat. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of said drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of imatinib mesylate in bulk drug and dosage forms. © 2006 Elsevier B.V. All rights reserved.

AB - A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of imatinib mesylate both as a bulk drug and in formulations was developed and validated. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of chloroform:methanol (6:4, v/v). The system was found to give compact spot for imatinib mesylate (Rf value of 0.53 ± 0.02). Densitometric analysis of imatinib mesylate was carried out in the absorbance mode at 276 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9966 ± 0.0013 with respect to peak area in the concentration range 100-1000 ng per spot. The mean value ± S.D. of slope and intercept were 164.85 ± 0.72 and 1168.3 ± 8.26 with respect to peak area. The method was validated for precision, recovery and robustness. The limits of detection and quantitation were 10 and 30 ng per spot, respectively. Imatinib mesylate was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and heat conditions. This indicates that the drug is susceptible to acid, base hydrolysis, oxidation and heat. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of said drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of imatinib mesylate in bulk drug and dosage forms. © 2006 Elsevier B.V. All rights reserved.

U2 - 10.1016/j.jpba.2006.07.022

DO - 10.1016/j.jpba.2006.07.022

M3 - Article

VL - 43

SP - 722

EP - 726

JO - Journal of Pharmaceutical and Biomedical Analysis

JF - Journal of Pharmaceutical and Biomedical Analysis

SN - 0731-7085

IS - 2

ER -