1Assistant Professor and Head Department of Pharmacognosy, Channabasweshwar Pharmacy College (Degree), Latur-413512, Affiliated to Swami Ramanand Teerth Marathwada University, Nanded, Maharashtra, India.
2Professor and Head Department of Pharmaceutical Chemistry, Channabasweshwar Pharmacy College (Degree), Latur-413512, Affiliated to Swami Ramanand Teerth Marathwada University, Nanded, Maharashtra, India.
3Research Scholar, Channabasweshwar Pharmacy College (Degree), Latur-413512, Affiliated to Swami Ramanand Teerth Marathwada University, Nanded, Maharashtra, India.
4Professor and Head, Department Of QA, Channabasweshwar Pharmacy College (Degree), Latur-413512, Affiliated to Swami Ramanand Teerth Marathwada University, Nanded, Maharashtra, India.
5Research Student, Department of Pharmaceutical Chemistry, Channabasweshwar Pharmacy College (Degree), Latur-413512, Affiliated to Swami Ramanand Teerth Marathwada University, Nanded, Maharashtra, India.
*Corresponding Author E-mail: sunil.pharmalink@gmail.com
A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantification of lamotrigine (LAM) in bulk and tablet dosage forms. The method was systematically optimized using a Quality-by-Design (QbD) framework with Central Composite Design (CCD), evaluating four critical parameters: column type, flow rate, detection wavelength, and mobile phase composition. Optimal chromatographic separation was achieved using an Intersil C8 column (250 mm × 4.6 mm) with a mobile phase of orthophosphoric acid and methanol (55:45v/v), at a flow rate of 1.0 mL/min. The method demonstrated excellent linearity (12.5-75ppm, R2 = 0.999), precision (%RSD = 0.5), and accuracy (mean recovery = 100.08%), and was validated in accordance with ICH guidelines Q2A and Q2B. Specificity was confirmed through forced degradation studies under acidic, basic, oxidative, thermal, photolytic, and neutral hydrolytic conditions. Maximum degradation was observed under alkaline (5.58%) and acidic (5.43%) stress, with distinct degradant peaks at retention times of 2.827-4.586min. Minimal degradation occurred under neutral (0.64%), thermal (2.30%), photolytic (1.57%), and oxidative (3.48%) conditions, confirming the method's ability to distinguish LAM from its degradation products. In alignment with green analytical chemistry principles, the method's environmental impact was assessed using the AGREE metric, yielding a favorable score of 0.82. The validated method is reliable, eco-conscious, and suitable for routine quality control of lamotrigine in pharmaceutical formulations.
Quality by Design, RP-HPLC, Lamotrigine, Central Composite Design, Estimation, Validation
