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Simple UV Spectrophotometric method development and Validation for determination of Lacosamide in bulk and its Tablet Dosage Form

R.Valarmathi*, S.Farisha Banu, R.Senthamarai, C.S. Dhivya Dhharshini
Department of Pharmaceutical Chemistry, Periyar College of Pharmaceutical Sciences, Tiruchirappalli, Tamilnadu, India.
Corresponding Author: R.Valarmathi Email: dharshavalar@yahoo.com
Received:02 February 2013 Accepted: 18 February 2013
Citation: R.Valarmathi, C. S. Dhivya Dhharshini, R. Senthamarai, S. Farisha Banu “Simple UV Spectrophotometric method development and Validation for determination of Lacosamide in bulk and its Tablet Dosage Form” Int. J. Drug Dev. & Res., January-March 2013, 5(1): 373-376.
Copyright: © 2013 IJDDR, R.Valarmathi et al. This is an open access paper distributed under the copyright agreement with Serials Publication, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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Abstract

A simple and reproducible UV spectroscopic methods have been developed and validated for the determination of lacosamide (LCM) in bulk and tablet dosage forms of two different brands. The standard and sample solutions were prepared using methanol: water (50:50 % v/v) as solvent. The maximum absorbance was obtained at 257 nm. Beer’s Lambert’s law was obeyed at the concentration range of 400 – 600 μg/ml and the correlation coefficient was found to be 0.9996. The developed method was validated according to ICH guidelines and was found to be accurate and precise for the determination of lacosamide in bulk and its tablet dosage form.



 

Key words:

Lacosamide, UV spectrophotometry, method development, tablet formulation.

INTRODUCTION

Lacosamide is the latest AED approved by US- FDA for adjunctive use in partial-onset seizures in patients 17 years of age and older [1,2]. It differs from all other approved AEDs in that it has two novel mechanisms of action and favourable pharmacokinetic and safety profiles. The potential for drug interactions with other AEDs and currently prescribed medications is very low. Overall there is a minimal dosing and clinical monitoring requirement with lacosamide. Lacosamide is ®-2-acetamido-N-benzyl-3- methoxypropionamide[3]. The structure is of lacosamide is given Fig.1. Lacosamide is a member of functionalized aminoacids. It occurs as a white to slight yellow crystalline powder with a molecular weight of 250.294 g/mol. It is soluble in organic solvents such as ethanol, DMSO and dimethyl formamide, slightly soluble in acetonitrile, soluble in phosphate buffered saline at pH 7.2.
Spectroscopic method using zero order method and under curve method have been reported so far[4,5]. Literature also reveals HPLC[6,7] and LCMS in tablet dosage form and in human and rat serum[8,9].
The aim of the present study is to develop a simple, sensitive and reproducible UV spectroscopic method for Lacosamide in bulk and its tablet dosage form. The developed method was validated according to ICH guidelines.

Chemicals and reagents

Lacosamide pure drug was obtained as a gift sample from Micro Labs, Chennai. Lacosamide tablets were procured from local pharmacy. The chemicals used for analysis are of analytical grade. Milli-Q water (Millipore Corporation, USA) was used. Methanol used was obtained from Merck Ltd. Mumbai.

Instrumentation

The analysis was carried out in Techcomp UV-2301 Spectrophotometer using methanol : water (50:50%v/v) as diluents at a maximum absorbance of 257 nm.

Preparation of standard stock solution

Standard stock solution of LCM was prepared by dissolving 312.5 mg in 25 ml methanol and 1 ml of this solution is further diluted to 25 ml using methanol : water, (50:50 v/v) to get a concentration of 500 μg. The resulting solution was scanned between 200 - 400 nm. The maximum absorbance was obtained at 257 nm. The UV spectrum of Lacosamide is given in Fig. 1.

MATERIALS AND METHODS

Preparation of sample solution

Sample solution was prepared using two different brands of lacosamide tablets by taking 20 tablets from each separately and accurately weighed and powdered. The powder weight equivalent to the label claim was transferred to 25 ml standard flask and to this 25 ml of methanol was added and the solution was ultrasonicated for 15 minutes. The 1 ml of this solution is transferred to 25 ml standard flask and made up to the volume using methanol : water mixture (50:50 v/v). The sample stock solution was filtered through Whatmann filter paper no.40 prior to use. The absorbance of the resulting solution was scanned at 257 nm. The amount of LCM present in each tablet is calculated using the absorbance value obtained. The assay results were given in Table 1.

RESULTS AND DISCUSSION

Method Validation

After the method development of UV Spectroscopy method, it has been validated according to ICH guidelines [10].

Linearity

Approximate volume of stock solution of 0.8, 0.9, 1.0, 1.1, 1.2 ml was diluted to 25 ml get a series of solutions containing 404.75, 462.55, 500.40, 562.90 and 604.60 μg/ml respectively. The solutions were scanned at 257 nm and a standard graph was drawn using absorbance versus concentrations. The graph was given in Fig.2.

Accuracy

Accuracy was established using nine determinations over three concentration levels which cover the specified range in triplicates. Results were given in Table 2.

Precision

Precision is the degree of agreement among individual test results when procedure is applied repeatedly with multiple samplings of a homogenous sample. Precision of Lacosamide was evaluated and the percentage relative standard deviation (%RSD) was found to be less than 1% which proves that the method was precise. Results were given in Table 3.

CONCLUSION

A rapid, accurate, precise and reproducible UV Spectroscopy method has been developed. The sample recoveries from the formulation was in good agreement with their respective label claims and the precision studies showed % RSD not less than 2. Hence this method can be used for the routine analysis of Lacosamide in bulk and its tablet dosage form.

ACKNOWLEDGEMENT

The authors express their gratitude to the Management, Periyar College of Pharmaceutical Sciences, Trichy for providing their continuous support throughout the work.

Tables at a glance

Table icon Table icon Table icon
Table 1 Table 2 Table 3
 

Figures at a glance

Figure 1 Figure 2 Figure 3
Figure 1 Figure 2 Figure 3
 

References

1) Kelemen and Halasz. Lacosamide for the Prevention of Partial Onset Seizures in Epileptic Adults.Neuropsychiatric Disease and Treatment.2010; 6: 465 - 471.

2) Beyreuther BK, Freitag J, Heers C, Krebsfanger N, Scharfenecker U, Stöhr T. Lacosamide: A review of preclinical properties. CNS Drug Rev. 2007; 13: 21- 42.

3) Vimpat® Approved in Europe.. UCB, Inc.Press Release September 3, 2008, Available from URL http://wwwucbcom/news/3606asp

4) SaiSumanth K, Jose GnanaBabu C, Ulaganathan, Muneer S, Balaji M. Validated spectrophotometric estimation of lacosamide in bulk and its tablet dosage form. International Journal of Pharmaceutical Research & Analysis. 2012; Vol 3(11): 78 - 82.

5) GanjiRamanaiah D, Ramachandran, Srinivas G, Srilakshmi, PurnachandaRao. 5. Development and validation of UV spectroscopy method for estimation of lacosamide in bulk and formulations. Int J Pharm Biomed Sci. 2012; 3(1): 10 -12.

 6) VudagandlaSreenivasulu, DokkuRaghavaRao, Uma MaheswariBN , Samar K Das, AbburiKrishnaiah. Development and validation of a stability-indicating RP – HPLC method for determination of lacosamide Research Journal of Pharmaceutical, Biological and Chemical Sciences. 2011; 2 (4): 1 - 11.

7) RamanaiahGanji, Ramachandran D , Srinivas G, Srilakshmi V, PurnachandaRao . Development and Validation of Stability Indicating RP-LC Method for Estimation of Lacosamide in Bulk and Its Pharmaceutical Formulations.Am. J. PharmTech Res. 2012; 2(2).

8) Kestelyn C, Lastelle M, Higuet N, Dell'Aiera S, Staelens L, Boulanger P, Boekens H, Smith S. A simple HPLC-UV method for the determination of lacosamide in human plasma.Bioanalysis. 2011 Nov;3 (22): 2515 - 22.

 9) KalyanChakravarthy V and GowriSankar D. Development and Validation of RP-HPLC method for estimation of lacosamide in bulk and its pharmaceutical formulation Rasayan Journal of Chemistry. 2011; 4(3): 666 - 672.

10) International Conference on Harmonization(ICH), Q2 (R1), Validation of Analytical Methods (Text and Methodology) 2000.
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