DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF LACOSAMIDE IN BULK AND TABLET DOSAGE FORM
To develop a simple, precise, accurate and reproducible spectrophotometry method for estimation of Lacosamide by employing first order derivative method and validate it as per ICH guidelines. The method is based on first order UV derivative spectrophotometry. Distilled water was selected as a solvent for estimation of Lacosamide with the absorption at 250 nm for quantification of Lacosamide. The linearity was established over the concentration range of 5-50 Âµg/ml for Lacosamide. The correlation coefficient (r2) for Lacosamide was 0.9980. The mean % recovery was found to be in range of 99.24% - 99.72% for Lacosamide. The results of analysis have been validated statistically and recovery studies confirmed the accuracy of the proposed method. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed method is recommended for routine analysis since it is rapid, simple, accurate, sensitive and specific.Key words: Lacosamide, Spectrophotometry, First order derivative,
2. 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; 22: 2515-22.
3. Chhalotiya UK, Bhatt KK, Shah DA, Baldania SL, Patel JR. Stability-indicating liquid chromatographic method for quantification of new anti-epileptic drug lacosamide in bulk and pharmaceutical formulation. Chemical Industry and Chemical Engineering Quarterly 2012; 18: 35-42
4. Kamdar SA, Vaghela VM, Desai PA. Development and Validation of HPTLC Method for Estimation of Lacosamide in Bulk Drug and in Tablet Dosage Form. International Journal of Chem Tech Research 2012; 4: 1193-1197.
5. Molleti S, Rao V, Jayaveera KN. Stability indicating reverse phase UPLC method for determination of lacosamide in bulk and pharmaceuticals dosage form.
Ber-pharma chemical 2013; 5: 81-89.
6. Kondawar MS, Shinde SR. Development and validation of bioanalytical method for lacosamide from rat brain tissue. International journal of pharm Tech research 2012; 4: 1417-1421.
7. ICH Harmonized Tripartite Guidelines, Validation of Analytical Procedures: Text and Methodology, Q2 (R1), Geneva, Nov 2005.
8. Rathod DR, Dole MN and Sawant SD. Spectrophotometric determination of Glipizide in bulk and tablet dosage form by absorption maxima, first order derivative spectroscopy and area under the curve. Asian J Pharm Clin Res 2012; 5(Suppl 3): 102-104.
9. Sengar MR, Gandhi SV, Patil UP and Rajmane VS. Simultaneous determination of Diclofenac Sodium and Thiocolchicoside in fixed dose combination by spectrophotometry. Asians J Pharm Clin Res 2010; 3 (Issue 2): 89-91.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.