Abstract
Objective of this study was to develop and validate HPLC-UV method for detection of LTG in lipid nanoformulations. HPLC-UV method was developed according to ICH Q2(R1) guidelines. Central composite design was used effectively to optimize and study the effect of buffer strength, flow rate, pH of buffer and mobile phase composition on responses such as tailing factor, peak area, retention time and number of theoretical plates. The 30 mM ammonium formate buffer and acetonitrile (in the ratio 65:35 %v/v) was used as mobile phase in the study. The mobile phase was delivered at the flow rate of 1.0 mL/min. The detection of buffer was performed at 256 nm using UV detector. The drug entrapment of prepared formulation was also determined using developed HPLC method. Retention time of lamotrigine was found to be 3.844 min. The coefficient of determination (r2) value from linearity was found to be 0.9982. Percent relative standard deviation value of precision was found to be within the acceptable range. The estimated LOD and LOQ were found to be 9.07 ng/mL and 27.48 ng/mL, respectively. Drug entrapment of prepared lipid nanoformulation was found to be 73.44 � 6.65%. The results conclude that the developed analytical method is simple, precise, sensitive, fast and reproducible. Applications of developed method for determination of drug entrapment in prepared lipid nanoformulation confirmed that the developed analytical method is suitable for estimation of lamotrigine in lipid nanoformulations.
Highlights
Lamotrigine is a phenyl triazine derivative, it was approved by United States Food and Drug Administration (USFDA) in 1994 for the treatment of epilepsy [1,2]
Lamotrigine is available as a tablet, but the problem with conventional tablets of lamotrigine is its lack of concentration in the brain after oral administration due to its low permeability through the blood brain barrier (BBB)
A full 4-factor-2-level Central composite design (CCD) design was employed to investigate the interaction between variables viz., strength of buffer, pH of buffer, flow rate and mobile phase ratio
Summary
Lamotrigine is a phenyl triazine derivative, it was approved by United States Food and Drug Administration (USFDA) in 1994 for the treatment of epilepsy [1,2]. This is widely used to treat generalized clonic-tonic seizures, partial seizures and Lennox-Gastaut syndrome. As the lamotrigine is not able to cross BBB which results in requirement of higher dose to achieve therapeutic effect. If higher dose is given by orally it causes increase in concentration of lamotrigine in systemic blood which results in hypersensitive reactions, rashes, Stevens-Johnson syndrome, epidermal necrosis, etc [1-4]
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