Author(s):
Hindole S. S., Panchabhai V.B., Moein S. Attar, Ram S Sakhare, Nandini Hotkar, Ankita Yadav
Email(s):
sunil.pharmalink@gmail.com
DOI:
10.52711/2231-5675.2026.00016 
Address:
Hindole S. S.1*, Panchabhai V.B.2, Moein S. Attar3, Ram S Sakhare4, Nandini Hotkar5, Ankita Yadav5
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 t
Published In:
Volume - 16,
Issue - 2,
Year - 2026
ABSTRACT:
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.
Cite this article:
Hindole S. S., Panchabhai V.B., Moein S. Attar, Ram S Sakhare, Nandini Hotkar, Ankita Yadav. Eco-Friendly QbD-Driven RP-HPLC Method for Stability Analysis of Lamotrigine. Asian Journal of Pharmaceutical Analysis. 2026; 16(2):109-3. doi: 10.52711/2231-5675.2026.00016
Cite(Electronic):
Hindole S. S., Panchabhai V.B., Moein S. Attar, Ram S Sakhare, Nandini Hotkar, Ankita Yadav. Eco-Friendly QbD-Driven RP-HPLC Method for Stability Analysis of Lamotrigine. Asian Journal of Pharmaceutical Analysis. 2026; 16(2):109-3. doi: 10.52711/2231-5675.2026.00016 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2026-16-2-6
REFERENCES:
1. Arnone D, et al. Efficacy of lamotrigine in the treatment of unipolar and bipolar depression: meta-analysis of acute and maintenance randomised controlled trials. Pharmaceuticals. 2025; 18: 1590.
2. Vinay KB, Revanasiddappa HD, Rajendraprasad N. Development and validation of spectrophotometric methods for the sensitive and selective determination of lamotrigine in pharmaceuticals using bromocresol purple. J Food Drug Anal. 2009; 17: 424–33.
3. Aboul-Kheir A, Saleh H, El-Henawee MM, Sharf El-Din M. Bromometric analysis of lamotrigine, minoxidil and cefixime. Asian J Pharm Anal. 2012; 2.
4. Prajapati PM, Shah T, Shah N, Parmar V, Solanki A. Green chemistry: a new way to prevent environmental pollution. Res J Sci Tech. 2011; 3: 12–6.
5. Gupta A, Singh Yadav J, Rawat S, Gandhi M. Method development and hydrolytic degradation study of doxofylline by RP-HPLC and LC-MS/MS. Asian J Pharm Anal. 2011; 1.
6. Masne DD, Chakole RD, Charde MS. QbD approached in method development, validation and degradation profiling of aripiprazole a antidepressent agent. Asian J Pharm Anal. 2022: 29–34.
7. Rajmane AD, Shinde KP. A review of HPLC method development and validation as per ICH guidelines. Asian J Pharm Anal. 2023: 143–51.
8. Mathew C, Varma S. Green analytical methods based on chemometrics and UV spectroscopy for the simultaneous estimation of empagliflozin and linagliptin. Asian J Pharm Anal. 2022: 43–8.
9. Priyadarshini GI, Mounika V, Anjani G, Sowmya B. Stability indicating RP-HPLC method development and validation for the simultaneous estimation of tezacaftor and ivacaftor in bulk and pharmaceutical dosage form. Asian J Pharm Anal. 2020; 10: 19.
10. Mondal P, Kola V. A new stability indicating validated RP-HPLC method for simultaneous estimation of escitalopram and clonazepam in bulk and tablet dosage form. Asian J Pharm Anal. 2019; 9: 193.
11. Perumal DD, Krishnan M, Lakshmi KS. Eco-friendly based stability-indicating RP-HPLC technique for the determination of escitalopram and etizolam by employing QbD approach. Green Chem Lett Rev. 2022; 15: 671–82.
12. Ahmad S, Ashwin B, Rahman BA, Gorad RU, Tare H. Quality by design (QbD) approach to develop stability indicating RP-HPLC method development for naproxen and pantoprazole. Int J Health Sci (Qassim). 2022: 818–32.
13. Venkateshwarlu P, Kumar DV, Madhusudhan M, Kumar BR, Rangaih KC. Green approach method development and validation by QbD-based liquid chromatographic method for estimation of favipiravir. Afr J Biol Sci. 2024; 6(15): 14614-24.
14. Babar AV, et al. QbD approach in HPLC method development and validation of tamoxifen. Int J Pharm Sci Med. 2022; 7: 90–105.
15. Jatte KP, Chakole RD, Charde MS. Degradation profiling of lisinopril and hydrochlorothiazide by RP-HPLC method with QbD approach. Asian J Pharm Anal. 2021: 270–4.
16. B M, Vinutha K, Seema R, P S. Development and validation of method for simultaneous estimation of remogliflozin, vildagliptin and metformin and its validation using ICH Q2R1. Asian J Pharm Anal. 2025: 40–4.
17. Pena-Pereira F, Wojnowski W, Tobiszewski M. AGREE - Analytical GREEnness metric approach and software. Anal Chem. 2020; 92: 10076–82.