High-performance thin-layer chromatographic method for analysis of racecadotril in the bulk drug

S.L. Prabu, T. Singh, C.D. Kumar, A. Joseph, K.K. Srinivasan

Research output: Contribution to journalArticle

Abstract

A new simple, rapid, reproducible, and stability-indicating high-performance thin-layer chromatographic method for analysis of racecadotril in the bulk drug and in a pharmaceutical formulation has been established and validated. Chromatographic separation was achieved on aluminum-backed silica gel 60F254 HPTLC plates with n -hexane-ethyl acetate 70:30 ( v / v ) as mobile phase. The method gives a compact band for racecadotril ( RF 0.59 ± 0.02) and enables excellent separation of its degradation products. Densitometric analysis of racecadotril was performed in absorbance mode at 230 nm. Linear regression analysis data for the calibration plots were indicative of a good linear relationship between peak area and concentration in the range 200-1600 ng per band (correlation coefficient 0.9975 ± 0.0002); the mean value of the slope and intercept were 2.176 ± 0.0239 and 88.98 ± 2.797, respectively. The method was validated for accuracy, precision, and recovery. The limits of detection and quantification were 50 and 100 ng per band respectively. Racecadotril was subjected to acid and alkaline hydrolysis, and oxidative degradation. The drug undergoes degradation under acidic, basic, and oxidizing conditions. Statistical analysis proves the method enables repeatable, selective, and accurate analysis of racecadotril and can be used for identification and quantification of racecadotril in the bulk drug and in a commercial oral solid dosage form. © Akadémiai Kiadó, Budapest.
Original languageEnglish
Pages (from-to)277-281
Number of pages5
JournalJournal of Planar Chromatography - Modern TLC
Volume22
Issue number4
DOIs
Publication statusPublished - 2009

Fingerprint

Thin Layer Chromatography
Pharmaceutical Preparations
Degradation
Drug Compounding
Silica Gel
Dosage Forms
Aluminum
Linear regression
Regression analysis
Calibration
Limit of Detection
racecadotril
Hydrolysis
Linear Models
Statistical methods
Regression Analysis
Recovery
Acids

Cite this

@article{2bd54f8d6cff43f9af1529967959eb33,
title = "High-performance thin-layer chromatographic method for analysis of racecadotril in the bulk drug",
abstract = "A new simple, rapid, reproducible, and stability-indicating high-performance thin-layer chromatographic method for analysis of racecadotril in the bulk drug and in a pharmaceutical formulation has been established and validated. Chromatographic separation was achieved on aluminum-backed silica gel 60F254 HPTLC plates with n -hexane-ethyl acetate 70:30 ( v / v ) as mobile phase. The method gives a compact band for racecadotril ( RF 0.59 ± 0.02) and enables excellent separation of its degradation products. Densitometric analysis of racecadotril was performed in absorbance mode at 230 nm. Linear regression analysis data for the calibration plots were indicative of a good linear relationship between peak area and concentration in the range 200-1600 ng per band (correlation coefficient 0.9975 ± 0.0002); the mean value of the slope and intercept were 2.176 ± 0.0239 and 88.98 ± 2.797, respectively. The method was validated for accuracy, precision, and recovery. The limits of detection and quantification were 50 and 100 ng per band respectively. Racecadotril was subjected to acid and alkaline hydrolysis, and oxidative degradation. The drug undergoes degradation under acidic, basic, and oxidizing conditions. Statistical analysis proves the method enables repeatable, selective, and accurate analysis of racecadotril and can be used for identification and quantification of racecadotril in the bulk drug and in a commercial oral solid dosage form. {\circledC} Akad{\'e}miai Kiad{\'o}, Budapest.",
author = "S.L. Prabu and T. Singh and C.D. Kumar and A. Joseph and K.K. Srinivasan",
note = "Export Date: 10 November 2017 CODEN: JPCTE Correspondence Address: Prabu, S. L.; Manipal College of Pharmaceutical Sciences, Manipal 576 104, India; email: slaxmanvel@gmail.com Chemicals/CAS: acetorphan, 81110-73-8 References: Matheson, A.J., Noble, S., (2000) Drugs, 59, p. 829; Cezard, J.P., Salazar-Lindo, E., (2005) Indian Pediatr., 42, pp. 502-503; Schwartz, J.C., (2000) Int. J. Antimicrob. Agents, 14, p. 75; Szajewska, H., Ruszczynski, M., Chmielewska, A., Wieczorek, J., (2007) Aliment. Pharmacol. Ther., 26, pp. 807-813; Xu, Y., Huang, J., Liu, F., Gao, S., Guo, Q., (2007) J. Chromatogr. B, 852, pp. 101-107; Reddy, K.M., Babu, J.M., Sudhakar, P., Sharma, M.S., Reddy, G.S., Vyas, K., (2006) Pharmazie, 61, pp. 994-998; Prabu, S.L., Singh, T., Joseph, A., Kumar, C.D., Shirwaikar, A., (2007) Ind. J. Pharm. Sci., 69, pp. 819-821; Xu, F., Yang, L., Xu, G., (2008) J. Chromatogr. B, 861, pp. 130-135; Prabu, S.L., Tarunveer, S., Alex, J., Kumar, C.D., Srinivasan, K.K., (2008) ARS. Pharm., 49, pp. 91-100; Vetrichelvan, T., Prabakaran, S., (2007) Ind. J. Pharm. Sci., 69, pp. 307-309",
year = "2009",
doi = "10.1556/JPC.22.2009.4.7",
language = "English",
volume = "22",
pages = "277--281",
journal = "Journal of Planar Chromatography - Modern TLC",
issn = "0933-4173",
publisher = "Research Institute for Medicinal Plants",
number = "4",

}

High-performance thin-layer chromatographic method for analysis of racecadotril in the bulk drug. / Prabu, S.L.; Singh, T.; Kumar, C.D.; Joseph, A.; Srinivasan, K.K.

In: Journal of Planar Chromatography - Modern TLC, Vol. 22, No. 4, 2009, p. 277-281.

Research output: Contribution to journalArticle

TY - JOUR

T1 - High-performance thin-layer chromatographic method for analysis of racecadotril in the bulk drug

AU - Prabu, S.L.

AU - Singh, T.

AU - Kumar, C.D.

AU - Joseph, A.

AU - Srinivasan, K.K.

N1 - Export Date: 10 November 2017 CODEN: JPCTE Correspondence Address: Prabu, S. L.; Manipal College of Pharmaceutical Sciences, Manipal 576 104, India; email: slaxmanvel@gmail.com Chemicals/CAS: acetorphan, 81110-73-8 References: Matheson, A.J., Noble, S., (2000) Drugs, 59, p. 829; Cezard, J.P., Salazar-Lindo, E., (2005) Indian Pediatr., 42, pp. 502-503; Schwartz, J.C., (2000) Int. J. Antimicrob. Agents, 14, p. 75; Szajewska, H., Ruszczynski, M., Chmielewska, A., Wieczorek, J., (2007) Aliment. Pharmacol. Ther., 26, pp. 807-813; Xu, Y., Huang, J., Liu, F., Gao, S., Guo, Q., (2007) J. Chromatogr. B, 852, pp. 101-107; Reddy, K.M., Babu, J.M., Sudhakar, P., Sharma, M.S., Reddy, G.S., Vyas, K., (2006) Pharmazie, 61, pp. 994-998; Prabu, S.L., Singh, T., Joseph, A., Kumar, C.D., Shirwaikar, A., (2007) Ind. J. Pharm. Sci., 69, pp. 819-821; Xu, F., Yang, L., Xu, G., (2008) J. Chromatogr. B, 861, pp. 130-135; Prabu, S.L., Tarunveer, S., Alex, J., Kumar, C.D., Srinivasan, K.K., (2008) ARS. Pharm., 49, pp. 91-100; Vetrichelvan, T., Prabakaran, S., (2007) Ind. J. Pharm. Sci., 69, pp. 307-309

PY - 2009

Y1 - 2009

N2 - A new simple, rapid, reproducible, and stability-indicating high-performance thin-layer chromatographic method for analysis of racecadotril in the bulk drug and in a pharmaceutical formulation has been established and validated. Chromatographic separation was achieved on aluminum-backed silica gel 60F254 HPTLC plates with n -hexane-ethyl acetate 70:30 ( v / v ) as mobile phase. The method gives a compact band for racecadotril ( RF 0.59 ± 0.02) and enables excellent separation of its degradation products. Densitometric analysis of racecadotril was performed in absorbance mode at 230 nm. Linear regression analysis data for the calibration plots were indicative of a good linear relationship between peak area and concentration in the range 200-1600 ng per band (correlation coefficient 0.9975 ± 0.0002); the mean value of the slope and intercept were 2.176 ± 0.0239 and 88.98 ± 2.797, respectively. The method was validated for accuracy, precision, and recovery. The limits of detection and quantification were 50 and 100 ng per band respectively. Racecadotril was subjected to acid and alkaline hydrolysis, and oxidative degradation. The drug undergoes degradation under acidic, basic, and oxidizing conditions. Statistical analysis proves the method enables repeatable, selective, and accurate analysis of racecadotril and can be used for identification and quantification of racecadotril in the bulk drug and in a commercial oral solid dosage form. © Akadémiai Kiadó, Budapest.

AB - A new simple, rapid, reproducible, and stability-indicating high-performance thin-layer chromatographic method for analysis of racecadotril in the bulk drug and in a pharmaceutical formulation has been established and validated. Chromatographic separation was achieved on aluminum-backed silica gel 60F254 HPTLC plates with n -hexane-ethyl acetate 70:30 ( v / v ) as mobile phase. The method gives a compact band for racecadotril ( RF 0.59 ± 0.02) and enables excellent separation of its degradation products. Densitometric analysis of racecadotril was performed in absorbance mode at 230 nm. Linear regression analysis data for the calibration plots were indicative of a good linear relationship between peak area and concentration in the range 200-1600 ng per band (correlation coefficient 0.9975 ± 0.0002); the mean value of the slope and intercept were 2.176 ± 0.0239 and 88.98 ± 2.797, respectively. The method was validated for accuracy, precision, and recovery. The limits of detection and quantification were 50 and 100 ng per band respectively. Racecadotril was subjected to acid and alkaline hydrolysis, and oxidative degradation. The drug undergoes degradation under acidic, basic, and oxidizing conditions. Statistical analysis proves the method enables repeatable, selective, and accurate analysis of racecadotril and can be used for identification and quantification of racecadotril in the bulk drug and in a commercial oral solid dosage form. © Akadémiai Kiadó, Budapest.

U2 - 10.1556/JPC.22.2009.4.7

DO - 10.1556/JPC.22.2009.4.7

M3 - Article

VL - 22

SP - 277

EP - 281

JO - Journal of Planar Chromatography - Modern TLC

JF - Journal of Planar Chromatography - Modern TLC

SN - 0933-4173

IS - 4

ER -