1,3Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India.
2M.Pharm. Ph.D., Department of Pharmaceutical Analysis, JSS College of Pharmacy, The Nilgiris, Ooty, Tamil Nadu, India-643001.
4MB School of Pharmaceutical Sciences, Mohan Babu University, Sree Sainath nagar, Tirupati-517102, India.
5Scitus Pharma Services Private Limited, Chennai-600 124, Tamilnadu, India
Levocarnitine Oral Solution (0.1 g/10 mL), an orphan drug product official in the USP monograph, lacks a compendial method for organic impurity determination. This study develops and validates a simple, cost-effective, high-performance liquid chromatography (HPLC) method for quantifying levocarnitine and related impurities in both sugar and sugar-free formulations, addressing this critical gap in quality control. The reversed-phase HPLC method employed a C18 column with gradient elution, achieving baseline resolution of levocarnitine (RT 4.6 min) and key impurities, including Levocarnitine Impurity-A (RT 4.9 min). Relative retention times (RRTs) and relative response factors (RRFs) were established for principal impurities. Per ICH Q2(R1) guidelines, comprehensive validation assessed specificity, system precision (RSD <1.0%), method precision (RSD <2.0%), LOQ precision (RSD <10%), linearity (r² >0.999 over LOQ to 300% specification level), accuracy (recovery 98-102%), robustness, ruggedness, and solution stability. Forced degradation studies under acidic, basic, oxidative, thermal, and photolytic conditions confirmed method specificity, demonstrating no interference from placebo, diluent, or degradation products. Solution stability at 25°C for 45 hours showed peak area variation <2.5%, affirming suitability for routine analysis. This sensitive, precise, and stability-indicating method provides a reliable tool for impurity profiling and quality assurance of levocarnitine oral solutions when compendial methods are unavailable, ensuring therapeutic product integrity.
Keywords: Levocarnitine HPLC, Method Validation, Organic Impurities, Specificity, Stability Indicating.
How to cite this article: R K, Babu B, M K, Jeyaprakash J, D RS. Development and Validation of a Stability-Indicating HPLC Method for Levocarnitine Oral Solution Impurity Profiling (USP SUGAR and SUGAR-FREE). Int J Drug Deliv Technol. 2026;16(3): 66-75. DOI: 10.25258/ijddt.16.3.9
Source of support: Nil.
Conflict of interest: None