Stability indicating HPLC determination of racecadotril in bulk drug and pharmaceutical dosage form

S. Lakshmana-Prabu, S. Tarunveer, A. Joseph, C. Dinesh Kumar, K.K. Srinivasan

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

A new simple, rapid, reproducible and stability indicating high performance liquid chromatographic method for the analysis of racecadotril in bulk drugs and from pharmaceutical formulation was developed and validated. The HPLC separation was achieved on a BDS -Hypersil C18column (250mm X 4.6mm, i.d. 5μm particle size) using a mobile phase consisting of a mixture of 20 mM phosphate buffer (pH 3.5) and acetonitrile in the ratio of (40:60) at a flow rate of 1 ml/min with detection at 230 nm. The linear regression analysis data for the calibration plots showed good linear relationship with the correlation coefficient of 0.999 with respect to peak area in the concentration range between 5 μg/ml and 15 μg/ml. The method was validated for precision, accuracy, recovery and robustness. The limit of detection and limit of quantitation were found to be 50 and 100 ng/ml respectively. Racecadotril was subjected to acid hydrolysis, alkali hydrolysis and oxidative degradation. The drug undergoes degradation under acidic, basic and oxidation conditions. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of racecadotril. The proposed developed HPLC method can be applied for identification and estimation of racecadotril in bulk drugs and marketed oral solid dosage forms.
Original languageEnglish
Pages (from-to)91-100
Number of pages10
JournalArs Pharmaceutica
Volume49
Issue number2
Publication statusPublished - 2008

Fingerprint

Dosage Forms
High Pressure Liquid Chromatography
Drug Compounding
Pharmaceutical Preparations
Hydrolysis
Alkalies
Particle Size
Calibration
Limit of Detection
Linear Models
Buffers
Phosphates
Regression Analysis
Acids
racecadotril
High-performance Liquid Chromatography
Drugs
Bulk
Pharmaceuticals
Degradation

Cite this

Lakshmana-Prabu, S., Tarunveer, S., Joseph, A., Dinesh Kumar, C., & Srinivasan, K. K. (2008). Stability indicating HPLC determination of racecadotril in bulk drug and pharmaceutical dosage form. Ars Pharmaceutica, 49(2), 91-100.
Lakshmana-Prabu, S. ; Tarunveer, S. ; Joseph, A. ; Dinesh Kumar, C. ; Srinivasan, K.K. / Stability indicating HPLC determination of racecadotril in bulk drug and pharmaceutical dosage form. In: Ars Pharmaceutica. 2008 ; Vol. 49, No. 2. pp. 91-100.
@article{ee02aa6ad6d04dca9d468e0177ff6c43,
title = "Stability indicating HPLC determination of racecadotril in bulk drug and pharmaceutical dosage form",
abstract = "A new simple, rapid, reproducible and stability indicating high performance liquid chromatographic method for the analysis of racecadotril in bulk drugs and from pharmaceutical formulation was developed and validated. The HPLC separation was achieved on a BDS -Hypersil C18column (250mm X 4.6mm, i.d. 5μm particle size) using a mobile phase consisting of a mixture of 20 mM phosphate buffer (pH 3.5) and acetonitrile in the ratio of (40:60) at a flow rate of 1 ml/min with detection at 230 nm. The linear regression analysis data for the calibration plots showed good linear relationship with the correlation coefficient of 0.999 with respect to peak area in the concentration range between 5 μg/ml and 15 μg/ml. The method was validated for precision, accuracy, recovery and robustness. The limit of detection and limit of quantitation were found to be 50 and 100 ng/ml respectively. Racecadotril was subjected to acid hydrolysis, alkali hydrolysis and oxidative degradation. The drug undergoes degradation under acidic, basic and oxidation conditions. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of racecadotril. The proposed developed HPLC method can be applied for identification and estimation of racecadotril in bulk drugs and marketed oral solid dosage forms.",
author = "S. Lakshmana-Prabu and S. Tarunveer and A. Joseph and {Dinesh Kumar}, C. and K.K. Srinivasan",
note = "Cited By :1 Export Date: 10 November 2017 Correspondence Address: Lakshmana-Prabu, S.; Manipal College of Pharmaceutical SciencesIndia; email: slaxmanvel@yahoo.com Chemicals/CAS: acetonitrile, 75-05-8; acetorphan, 81110-73-8; phosphate, 14066-19-4, 14265-44-2 Tradenames: zedott Manufacturers: Reddy, India References: Schwartz, J.C., Racecadotril: A new approach to the treatment of diarrhoea (2000) Int J Antimicrob Agents, 14, pp. 75-79; Xu, Y., Huang, J., Liu, F., Gao, S., Guo, Q., Quantitative analysis of racecadotril metabolite in human plasma using a liquid chromatography/tandem mass spectrometry (2007) J Chromatogr. B, 852, pp. 101-107; Reddy, K.M., Babu, J.M., Sudhakar, P., Sharma, M.S., Reddy, G.S., Vyas, K., Structural studies of racecadotril and its process impurities by NMR and mass spectroscopy (2006) Pharmazie, 61, pp. 994-998",
year = "2008",
language = "English",
volume = "49",
pages = "91--100",
journal = "Ars Pharmaceutica",
issn = "0004-2927",
publisher = "Editorial Universida de Granada",
number = "2",

}

Lakshmana-Prabu, S, Tarunveer, S, Joseph, A, Dinesh Kumar, C & Srinivasan, KK 2008, 'Stability indicating HPLC determination of racecadotril in bulk drug and pharmaceutical dosage form', Ars Pharmaceutica, vol. 49, no. 2, pp. 91-100.

Stability indicating HPLC determination of racecadotril in bulk drug and pharmaceutical dosage form. / Lakshmana-Prabu, S.; Tarunveer, S.; Joseph, A.; Dinesh Kumar, C.; Srinivasan, K.K.

In: Ars Pharmaceutica, Vol. 49, No. 2, 2008, p. 91-100.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Stability indicating HPLC determination of racecadotril in bulk drug and pharmaceutical dosage form

AU - Lakshmana-Prabu, S.

AU - Tarunveer, S.

AU - Joseph, A.

AU - Dinesh Kumar, C.

AU - Srinivasan, K.K.

N1 - Cited By :1 Export Date: 10 November 2017 Correspondence Address: Lakshmana-Prabu, S.; Manipal College of Pharmaceutical SciencesIndia; email: slaxmanvel@yahoo.com Chemicals/CAS: acetonitrile, 75-05-8; acetorphan, 81110-73-8; phosphate, 14066-19-4, 14265-44-2 Tradenames: zedott Manufacturers: Reddy, India References: Schwartz, J.C., Racecadotril: A new approach to the treatment of diarrhoea (2000) Int J Antimicrob Agents, 14, pp. 75-79; Xu, Y., Huang, J., Liu, F., Gao, S., Guo, Q., Quantitative analysis of racecadotril metabolite in human plasma using a liquid chromatography/tandem mass spectrometry (2007) J Chromatogr. B, 852, pp. 101-107; Reddy, K.M., Babu, J.M., Sudhakar, P., Sharma, M.S., Reddy, G.S., Vyas, K., Structural studies of racecadotril and its process impurities by NMR and mass spectroscopy (2006) Pharmazie, 61, pp. 994-998

PY - 2008

Y1 - 2008

N2 - A new simple, rapid, reproducible and stability indicating high performance liquid chromatographic method for the analysis of racecadotril in bulk drugs and from pharmaceutical formulation was developed and validated. The HPLC separation was achieved on a BDS -Hypersil C18column (250mm X 4.6mm, i.d. 5μm particle size) using a mobile phase consisting of a mixture of 20 mM phosphate buffer (pH 3.5) and acetonitrile in the ratio of (40:60) at a flow rate of 1 ml/min with detection at 230 nm. The linear regression analysis data for the calibration plots showed good linear relationship with the correlation coefficient of 0.999 with respect to peak area in the concentration range between 5 μg/ml and 15 μg/ml. The method was validated for precision, accuracy, recovery and robustness. The limit of detection and limit of quantitation were found to be 50 and 100 ng/ml respectively. Racecadotril was subjected to acid hydrolysis, alkali hydrolysis and oxidative degradation. The drug undergoes degradation under acidic, basic and oxidation conditions. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of racecadotril. The proposed developed HPLC method can be applied for identification and estimation of racecadotril in bulk drugs and marketed oral solid dosage forms.

AB - A new simple, rapid, reproducible and stability indicating high performance liquid chromatographic method for the analysis of racecadotril in bulk drugs and from pharmaceutical formulation was developed and validated. The HPLC separation was achieved on a BDS -Hypersil C18column (250mm X 4.6mm, i.d. 5μm particle size) using a mobile phase consisting of a mixture of 20 mM phosphate buffer (pH 3.5) and acetonitrile in the ratio of (40:60) at a flow rate of 1 ml/min with detection at 230 nm. The linear regression analysis data for the calibration plots showed good linear relationship with the correlation coefficient of 0.999 with respect to peak area in the concentration range between 5 μg/ml and 15 μg/ml. The method was validated for precision, accuracy, recovery and robustness. The limit of detection and limit of quantitation were found to be 50 and 100 ng/ml respectively. Racecadotril was subjected to acid hydrolysis, alkali hydrolysis and oxidative degradation. The drug undergoes degradation under acidic, basic and oxidation conditions. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of racecadotril. The proposed developed HPLC method can be applied for identification and estimation of racecadotril in bulk drugs and marketed oral solid dosage forms.

M3 - Article

VL - 49

SP - 91

EP - 100

JO - Ars Pharmaceutica

JF - Ars Pharmaceutica

SN - 0004-2927

IS - 2

ER -

Lakshmana-Prabu S, Tarunveer S, Joseph A, Dinesh Kumar C, Srinivasan KK. Stability indicating HPLC determination of racecadotril in bulk drug and pharmaceutical dosage form. Ars Pharmaceutica. 2008;49(2):91-100.