Limits...
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.


Related in: MedlinePlus

Chromatograms of eslicarbazepine acetate.Chromatograms of eslicarbazepine acetate standard (a) and test (b).
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Figure 2: Chromatograms of eslicarbazepine acetate.Chromatograms of eslicarbazepine acetate standard (a) and test (b).

Mentions: The analytical method was optimised by varying the ratio of mobile phase. A 70:30 ratio of methanol and 0.005 M ammonium acetate was found to give the best system suitability parameters. The criteria for the selection of mobile phase and its composition were symmetry, shape and retention time of the peak. The selection of buffer is due to its slightly neutral pH, which is safe for column life and suitable for analyte stability, whereas methanol is readily available solvent. Considering the already proposed methods in literature, the advantages of this new proposed method are rapid results (retention time 4.9 min), quick analysis time (run time 10 min), economic mobile phase, user friendly and convenient approach. All these key features proposed that this method can be considered as advantageous over other methods (fig. 2).


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)

Chromatograms of eslicarbazepine acetate.Chromatograms of eslicarbazepine acetate standard (a) and test (b).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 2: Chromatograms of eslicarbazepine acetate.Chromatograms of eslicarbazepine acetate standard (a) and test (b).
Mentions: The analytical method was optimised by varying the ratio of mobile phase. A 70:30 ratio of methanol and 0.005 M ammonium acetate was found to give the best system suitability parameters. The criteria for the selection of mobile phase and its composition were symmetry, shape and retention time of the peak. The selection of buffer is due to its slightly neutral pH, which is safe for column life and suitable for analyte stability, whereas methanol is readily available solvent. Considering the already proposed methods in literature, the advantages of this new proposed method are rapid results (retention time 4.9 min), quick analysis time (run time 10 min), economic mobile phase, user friendly and convenient approach. All these key features proposed that this method can be considered as advantageous over other methods (fig. 2).

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