Development and Validation of Stability Indicating RP-HPLC Method For Quantification of Baclofen and Its Related Substance In Tablet Dosage Form

Abstract

Baclofen is a muscle relaxant used as first option to treat spasticity and muscle spasms in patients with spinal cord injuries. A rapid, selective and sensitive RP-HPLC method was developed for determination of Baclofen and its related substance in tablet dosage form. The chromatographic separation of Baclofen was carried out by using C18 column (250 x 4.6 mm), 5μm with buffer as mobile phase A, and mixture of acetonitrile and methanol in the ratio of 50:50 % V/V using as mobile phase B. The flow rate was 0.8mL/min with gradient elution mode and wavelength for detection was 220 nm. Retention time for Baclofen peak was found 7.780 min and impurity peak was 15.340 min, Method selectivity was demonstrated by the forced degradation study. The developed method was specific, accurate as per ICH guidelines. The system suitability criteria were found to be within limits. The limit of detection was found to be 0.01 μg/mL for impurity A and 0.01μg/mL for Baclofen and Limit of quantification was found to be 0.04μg/mL for impurity A and 0.03μg/mL for Baclofen. The linearity curve was found to be linear and the correlation coefficient for Baclofen obtained was 0.9997 and 0.9999 for impurity A The average percentage of recovery found in the range of 97-101%.