High-performance thin-layer chromatographic analysis of bicalutamide in bulk drug and liposomes

G.S. Subramanian, A. Karthik, A. Baliga, P. Musmade, S. Kini

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

A sensitive, accurate, precise, and specific high-performance thin-layer chromatographic (HPTLC) method for analysis of bicalutamide in the bulk drug and in a liposomal formulation containing cholesterol and lecithin and other surfactants has been established and validated in accordance with ICH guidelines. HPTLC on aluminum foil-backed silica gel 60F-254 plates with toluene-ethyl acetate 4.5:5.5 ( v / v ) as mobile phase gave compact bands for bicalutamide ( RF 0.45). Leflunomide ( RF 0.85) was used as internal standard. Densitometric analysis of bicalutamide was performed in absorbance mode at 273 nm. The method was validated for accuracy, precision, linearity, robustness, and limits of detection and quantitation. The method is specific, selective, and free from matrix interferences at the RF of bicalutamide and the internal standard. Regression data for the calibration plots were indicative of a good linear relationship (correlation coefficient 0.9994 ± 0.002) between response and amount of bicalutamide in the concentration range 200-1600 ng per band. The limits of detection and quantitation were 50 and 200 ng per band, respectively. © Akadémiai Kiadó, Budapest.
Original languageEnglish
Pages (from-to)273-276
Number of pages4
JournalJournal of Planar Chromatography - Modern TLC
Volume22
Issue number4
DOIs
Publication statusPublished - 2009

Fingerprint

Thin layer chromatography
Thin Layer Chromatography
Liposomes
Pharmaceutical Preparations
leflunomide
Limit of Detection
Aluminum foil
Lecithins
Silica Gel
Toluene
Aluminum
Surface-Active Agents
Calibration
Cholesterol
bicalutamide
Guidelines

Cite this

Subramanian, G.S. ; Karthik, A. ; Baliga, A. ; Musmade, P. ; Kini, S. / High-performance thin-layer chromatographic analysis of bicalutamide in bulk drug and liposomes. In: Journal of Planar Chromatography - Modern TLC. 2009 ; Vol. 22, No. 4. pp. 273-276.
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author = "G.S. Subramanian and A. Karthik and A. Baliga and P. Musmade and S. Kini",
note = "Cited By :4 Export Date: 10 November 2017 CODEN: JPCTE Correspondence Address: Subramanian, G. S.; Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka 576104, India; email: ganrajesh@gmail.com Chemicals/CAS: bicalutamide, 90357-06-5; cholesterol, 57-88-5; leflunomide, 75706-12-6; phosphatidylcholine, 55128-59-1, 8002-43-5 References: Kolvenbag, G.J., Nash, A., (1999) Prostate, 39, pp. 47-53; Kolvenbag, G.J., Blackledge, G.R., Gotting Smith, K., (1998) Prostate, 34, pp. 61-72; Boccardo, F., Barichello, M., Battaglia, M., Carmignani, G., Comeri, G., Ferraris, V., (2002) Eur. Urol., 42, pp. 481-490; Wirth, M., Iversen, P., McLeod, D., See, W., (2002) Eur. Urol., 1 (7 SUPPL.), pp. 20-25; George, R.P., Blackledge, M.D., (1996) Urology, 47, pp. S44-S47; See, W.A., McLeod, D., Iversen, P., Wirth, M., (2001) Urol. Oncol., 6, pp. 43-47; Tyrrell, C.J., Payne, H., See, W.A., McLeod, D.G., Wirth, M.P., Iversen, P., (2005) Radiother. Oncol., 76, pp. 4-10; T{\"o}r{\"o}k, R., Bor, A., Orosz, G., Luk{\'a}cs, F., Armstrong, D.W., P{\'e}ter, A., (2005) J. Chromatogr. A, 1098, pp. 75-81; Rao, R.N., Raju, A.N., Nagaraju, D., (2006) J. Pharm. Biomed. Anal., 42, pp. 347-353; Cockshott, I.D., Oliver, S.D., Young, J.J., Cooper, K.J., Jones, D.C., (1997) Biophar. Drug Dispos., 18, pp. 499-507; Saravanan, G., Rao, B.M., Ravikumar, M., Suryanarayana, M.V., Someswararao, N., Acharulu, P.V.R., (2007) Chromatographia, 66, pp. 219-222; Nageswara Rao, N., Narasa Raju, A., Narasimha, R., (2008) J. Pharm. Biomed. Anal., 46, pp. 505-519; (2005) International Conference on Harmonization (ICH), Q2 (R1), Validation of Analytical Procedure: Text and Methodology, , Geneva, Switzerland",
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High-performance thin-layer chromatographic analysis of bicalutamide in bulk drug and liposomes. / Subramanian, G.S.; Karthik, A.; Baliga, A.; Musmade, P.; Kini, S.

In: Journal of Planar Chromatography - Modern TLC, Vol. 22, No. 4, 2009, p. 273-276.

Research output: Contribution to journalArticle

TY - JOUR

T1 - High-performance thin-layer chromatographic analysis of bicalutamide in bulk drug and liposomes

AU - Subramanian, G.S.

AU - Karthik, A.

AU - Baliga, A.

AU - Musmade, P.

AU - Kini, S.

N1 - Cited By :4 Export Date: 10 November 2017 CODEN: JPCTE Correspondence Address: Subramanian, G. S.; Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka 576104, India; email: ganrajesh@gmail.com Chemicals/CAS: bicalutamide, 90357-06-5; cholesterol, 57-88-5; leflunomide, 75706-12-6; phosphatidylcholine, 55128-59-1, 8002-43-5 References: Kolvenbag, G.J., Nash, A., (1999) Prostate, 39, pp. 47-53; Kolvenbag, G.J., Blackledge, G.R., Gotting Smith, K., (1998) Prostate, 34, pp. 61-72; Boccardo, F., Barichello, M., Battaglia, M., Carmignani, G., Comeri, G., Ferraris, V., (2002) Eur. Urol., 42, pp. 481-490; Wirth, M., Iversen, P., McLeod, D., See, W., (2002) Eur. Urol., 1 (7 SUPPL.), pp. 20-25; George, R.P., Blackledge, M.D., (1996) Urology, 47, pp. S44-S47; See, W.A., McLeod, D., Iversen, P., Wirth, M., (2001) Urol. Oncol., 6, pp. 43-47; Tyrrell, C.J., Payne, H., See, W.A., McLeod, D.G., Wirth, M.P., Iversen, P., (2005) Radiother. Oncol., 76, pp. 4-10; Török, R., Bor, A., Orosz, G., Lukács, F., Armstrong, D.W., Péter, A., (2005) J. Chromatogr. A, 1098, pp. 75-81; Rao, R.N., Raju, A.N., Nagaraju, D., (2006) J. Pharm. Biomed. Anal., 42, pp. 347-353; Cockshott, I.D., Oliver, S.D., Young, J.J., Cooper, K.J., Jones, D.C., (1997) Biophar. Drug Dispos., 18, pp. 499-507; Saravanan, G., Rao, B.M., Ravikumar, M., Suryanarayana, M.V., Someswararao, N., Acharulu, P.V.R., (2007) Chromatographia, 66, pp. 219-222; Nageswara Rao, N., Narasa Raju, A., Narasimha, R., (2008) J. Pharm. Biomed. Anal., 46, pp. 505-519; (2005) International Conference on Harmonization (ICH), Q2 (R1), Validation of Analytical Procedure: Text and Methodology, , Geneva, Switzerland

PY - 2009

Y1 - 2009

N2 - A sensitive, accurate, precise, and specific high-performance thin-layer chromatographic (HPTLC) method for analysis of bicalutamide in the bulk drug and in a liposomal formulation containing cholesterol and lecithin and other surfactants has been established and validated in accordance with ICH guidelines. HPTLC on aluminum foil-backed silica gel 60F-254 plates with toluene-ethyl acetate 4.5:5.5 ( v / v ) as mobile phase gave compact bands for bicalutamide ( RF 0.45). Leflunomide ( RF 0.85) was used as internal standard. Densitometric analysis of bicalutamide was performed in absorbance mode at 273 nm. The method was validated for accuracy, precision, linearity, robustness, and limits of detection and quantitation. The method is specific, selective, and free from matrix interferences at the RF of bicalutamide and the internal standard. Regression data for the calibration plots were indicative of a good linear relationship (correlation coefficient 0.9994 ± 0.002) between response and amount of bicalutamide in the concentration range 200-1600 ng per band. The limits of detection and quantitation were 50 and 200 ng per band, respectively. © Akadémiai Kiadó, Budapest.

AB - A sensitive, accurate, precise, and specific high-performance thin-layer chromatographic (HPTLC) method for analysis of bicalutamide in the bulk drug and in a liposomal formulation containing cholesterol and lecithin and other surfactants has been established and validated in accordance with ICH guidelines. HPTLC on aluminum foil-backed silica gel 60F-254 plates with toluene-ethyl acetate 4.5:5.5 ( v / v ) as mobile phase gave compact bands for bicalutamide ( RF 0.45). Leflunomide ( RF 0.85) was used as internal standard. Densitometric analysis of bicalutamide was performed in absorbance mode at 273 nm. The method was validated for accuracy, precision, linearity, robustness, and limits of detection and quantitation. The method is specific, selective, and free from matrix interferences at the RF of bicalutamide and the internal standard. Regression data for the calibration plots were indicative of a good linear relationship (correlation coefficient 0.9994 ± 0.002) between response and amount of bicalutamide in the concentration range 200-1600 ng per band. The limits of detection and quantitation were 50 and 200 ng per band, respectively. © Akadémiai Kiadó, Budapest.

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DO - 10.1556/JPC.22.2009.4.6

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SP - 273

EP - 276

JO - Journal of Planar Chromatography - Modern TLC

JF - Journal of Planar Chromatography - Modern TLC

SN - 0933-4173

IS - 4

ER -