Abstract
A simple, rapid, specific, precise and accurate HPLC method has been developed for the estimation of Pregabalin in bulk drugs and in capsule dosage forms. The mobile phase consisted of 80: 10: 10 (v/v/v) of Disodium Hydrogen Phosphate Buffer: Acetonitrile: Methanol. The flow rate is 1 ml/min. Chromatographic determination of Pregabalin was performed on Inertsil ODS -3V, C18 (250 X 4.6 mm Id, 5μm) column. The wavelength of detection is 210 nm. The injection volume is 20μL. The retention time of Pregabalin is 4.7 minutes. The developed method was validated in terms of specificity, accuracy, precision, linearity, solution stability, ruggedness, robustness and system suitability. The influence of Acid, Alkaline, Oxidative Stress, Photolytic stress, Thermal stress, and Humidity stress conditions on pregabalin was studied. Results indicated that Pregabalin is stable under the experimental conditions. The proposed method has been successfully used for the routine analysis of pregabalin in capsule dosage forms.
Highlights
Pregabalin [1] chemically known as (S)-2(amino methyl)-5-methyl hexanoicacid (Figure 1), is a white crystalline solid, which is soluble in water and in both basic and acidic aqueous solution sand used as anticonvulsant, analgesic medication and neurotransmitter. [2,3] Pregabalin is the 3 isobutyl substituted analogue of δ amino butyric acid (GABA) but is inactive at GABA receptors
Pregabalin approved for a number of indications in the US and Europe that include adjunctive therapy of partial seizures in adults, pain from diabetic neuropathy or post-herpetic neuralgia in adults, and the treatment of anxiety disorders
A new validated HPLC method [18] was developed for determination of pregabalin in bulk drug and capsule dosage forms
Summary
Pregabalin [1] chemically known as (S)-2(amino methyl)-5-methyl hexanoicacid (Figure 1), is a white crystalline solid, which is soluble in water and in both basic and acidic aqueous solution sand used as anticonvulsant, analgesic medication and neurotransmitter. [2,3] Pregabalin is the 3 isobutyl substituted analogue of δ amino butyric acid (GABA) but is inactive at GABA receptors. [4] This drug produces its actions by binding to the alpha 2 delta (α2δ) subunit of the voltage gated calcium channels. A new validated HPLC method [18] was developed for determination of pregabalin in bulk drug and capsule dosage forms. All of these methods are very expensive because these methods require long and tedious pre-treatment of the samples, laborious clean up procedures and derivatization for the analysis of pregabalin. It requires simple new HPLC method for analysis of pregabalin in bulk and the determination of pregabalin in capsules. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
