Abstract
Pregabalin an antiepileptic was the first compound approved by FDA for treating chronic pain. A sensitive, efficient, economical, environmental friendly and isocratic liquid chromatographic method for the determination of pregabalin in bulk drug, pharmaceutical dosage forms and human serum has been developed and validated according to ICH guidelines. Chromatographic separation was performed on a KROMASIL® 100-5 C-18 column (250×4.6 i.d. mm) (5 μm particle size) as stationary phase with a UV detection at 210 nm using isocratic elution when buffer pH 7 and acetonitrile (96:4, v/v) were used as the mobile phase and the flow rate was 1 ml min-1 at ambient temperature,the retention time was 4.6 minutes.The method showed good linearity in the range 1-25 μg mL-1 with R2>0.999. The lower limit of detection (LLOD) and quantitation (LLOQ) were 10 ng mL-1 and 17 ng mL-1 and 0.04 and 0.12 ng mL-1 for drug and serum, respectively. Validation of the method showed good precision and accuracy for the proposed method. The newly developed method can be successfully applied for the determination of pregabalin in active pharmaceutical ingredients, pharmaceutical formulations, human serum and could be used in therapeutic drug monitoring and clinical laboratories without diode array detector and without interference of excipients or endogenous components of serum.
Highlights
Pregabalin (Figure 1) is a derivative of the inhibitory neurotransmitter γ-aminobutyric acid (GABA)
In the United States it is the latest addition to the antiepileptic medication, approved by FDA in 2005 for partial epilepsy, painful diabetic polyneuropathy, postherpetic neuralgia and fibromyalgia [1,2,3,4]
Pregabalin is useful for treating any supplementary situation, pain, physiological conditions associated with psychomotor stimulants, inflammation, gastrointestinal damage, alcoholism, insomnia and various psychiatric disorders, including mania and bipolar disorder and has been shown to be effective in several animal models of inflammatory and neuropathic pain [1]
Summary
Pregabalin (Figure 1) is a derivative of the inhibitory neurotransmitter γ-aminobutyric acid (GABA). A2δ ligands are used for the treatment of pain of diabetic neuropathy and postherpetic neuralgia [1]. Pregabalin is useful for treating any supplementary situation, pain, physiological conditions associated with psychomotor stimulants, inflammation, gastrointestinal damage, alcoholism, insomnia and various psychiatric disorders, including mania and bipolar disorder and has been shown to be effective in several animal models of inflammatory and neuropathic pain [1].
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