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Development and Validation of an RP-HPLC Method for Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Tablets.

Singh M, Kumar L, Arora P, Mathur SC, Saini PK, Singh RM, Singh GN - Indian J Pharm Sci (2013)

Bottom Line: The limit of detection and quantification were found to be 3.144 and 9.52 μg/ml, respectively.The amount of eslicarbazepine acetate in bulk and tablet dosage form was found to be 99.19 and 97.88%, respectively.The recovery studies were performed and the percentage recoveries were found to be 98.33± 0.5%.

View Article: PubMed Central - PubMed

Affiliation: Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.

ABSTRACT
A convenient, simple, accurate, precise and reproducible RP-HPLC method was developed and validated for the estimation of eslicarbazepine acetate in bulk drug and tablet dosage form. Objective was achieved under optimised chromatographic conditions on Dionex RP-HPLC system with Dionex C18 column (250×4.6 mm, 5 μm particle size) using mobile phase composed of methanol and ammonium acetate (0.005 M) in the ratio of 70:30 v/v. The separation was achieved using an isocratic elution method with a flow rate of 1.0 ml/ min at room temperature. The effluent was monitored at 230 nm using diode array detector. The retention time of eslicarbazepine acetate is found to be 4.9 min and the standard calibration plot was linear over a concentration range of 10-90 μg/ml with r(2)=0.9995. The limit of detection and quantification were found to be 3.144 and 9.52 μg/ml, respectively. The amount of eslicarbazepine acetate in bulk and tablet dosage form was found to be 99.19 and 97.88%, respectively. The method was validated statistically using the percent relative standard deviation and the values are found to be within the limits. The recovery studies were performed and the percentage recoveries were found to be 98.33± 0.5%.

No MeSH data available.


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Chemical structure of eslicarbazepine acetate.
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Figure 1: Chemical structure of eslicarbazepine acetate.

Mentions: Eslicarbazepine acetate chemically known as (S)-10-acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide (fig. 1), is a new broad spectrum antiepileptic drug. Eslicarbazepine acetate is effective for the treatment of partial and generalised tonic-clonic seizures as a single drug or as an adjuvant with other antiepileptic drug[123456]. Literature survey reveals that no pharmacopoeial method is available in Indian Pharmacopoeia, British Pharmacopoeia and United States Pharmacopoeia. However some high-performance liquid chromatography (HPLC) methods have been reported for the quantification of eslicarbazepine acetate in pharmaceutical dosage forms[78910]. Present study involves development of a convenient, rapid and user friendly reversed-phase (RP)-HPLC method with a simple and easily available mobile phase for quantitative estimation of eslicarbazepine acetate in bulk drug and tablet dosage form. The optimised method was developed and validated as per International Conference on Harmonisation (ICH) guidelines[11].


Development and Validation of an RP-HPLC Method for Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Tablets.

Singh M, Kumar L, Arora P, Mathur SC, Saini PK, Singh RM, Singh GN - Indian J Pharm Sci (2013)

Chemical structure of eslicarbazepine acetate.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3928741&req=5

Figure 1: Chemical structure of eslicarbazepine acetate.
Mentions: Eslicarbazepine acetate chemically known as (S)-10-acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide (fig. 1), is a new broad spectrum antiepileptic drug. Eslicarbazepine acetate is effective for the treatment of partial and generalised tonic-clonic seizures as a single drug or as an adjuvant with other antiepileptic drug[123456]. Literature survey reveals that no pharmacopoeial method is available in Indian Pharmacopoeia, British Pharmacopoeia and United States Pharmacopoeia. However some high-performance liquid chromatography (HPLC) methods have been reported for the quantification of eslicarbazepine acetate in pharmaceutical dosage forms[78910]. Present study involves development of a convenient, rapid and user friendly reversed-phase (RP)-HPLC method with a simple and easily available mobile phase for quantitative estimation of eslicarbazepine acetate in bulk drug and tablet dosage form. The optimised method was developed and validated as per International Conference on Harmonisation (ICH) guidelines[11].

Bottom Line: The limit of detection and quantification were found to be 3.144 and 9.52 μg/ml, respectively.The amount of eslicarbazepine acetate in bulk and tablet dosage form was found to be 99.19 and 97.88%, respectively.The recovery studies were performed and the percentage recoveries were found to be 98.33± 0.5%.

View Article: PubMed Central - PubMed

Affiliation: Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.

ABSTRACT
A convenient, simple, accurate, precise and reproducible RP-HPLC method was developed and validated for the estimation of eslicarbazepine acetate in bulk drug and tablet dosage form. Objective was achieved under optimised chromatographic conditions on Dionex RP-HPLC system with Dionex C18 column (250×4.6 mm, 5 μm particle size) using mobile phase composed of methanol and ammonium acetate (0.005 M) in the ratio of 70:30 v/v. The separation was achieved using an isocratic elution method with a flow rate of 1.0 ml/ min at room temperature. The effluent was monitored at 230 nm using diode array detector. The retention time of eslicarbazepine acetate is found to be 4.9 min and the standard calibration plot was linear over a concentration range of 10-90 μg/ml with r(2)=0.9995. The limit of detection and quantification were found to be 3.144 and 9.52 μg/ml, respectively. The amount of eslicarbazepine acetate in bulk and tablet dosage form was found to be 99.19 and 97.88%, respectively. The method was validated statistically using the percent relative standard deviation and the values are found to be within the limits. The recovery studies were performed and the percentage recoveries were found to be 98.33± 0.5%.

No MeSH data available.


Related in: MedlinePlus