New Validated UV-Spectrophotometric Method for the Determination of a New Pregabalin Derivative in Capsule Dosage Form (Research Article)

Author(s): S. Deepthi, G. Divya, D. Joyce Sharon, V. Sandhya, J. Deepthi Akanksha, P. Vivek Sagar and K. Sirisha*

Abstract: Pregabalin, an anti-epileptic drug has very low UV absorptivity and hence normally it is difficult to analyze this drug by UV Spectroscopy. Benzene sulfonyl chloride, a derivatizing agent, was used to introduce a chromogen for the purpose of detecting pregabalin in bulk and capsules. A wavelength of 205nm was used to find the pregabalin after derivatization by UV-spectroscopy. The spectrophotometric validation parameters such as linearity, precision, accuracy, robustness, and ruggedness were studied and verified using the ICH guidelines. With a correlation coefficient of 0.999, the linearity between 20μg/ml and 100μg/ml was observed. The intermediate and intraday precision’s respective RSDs were found to be 1.27% and 1.40%. The accuracy concentration range was spiked at 50%, 100%, and 150%, and the %recovery values were found to be in the range of 95.7% to 99.4%. The method was found to be rugged and robust. Without any interference from typical excipients, the devised approach was effectively verified and applied to the detection of pregabalin in bulk and pharmaceutical formulation. Keywords Absorbance, Derivative, Methanol, Pregabalin, UV

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