Forced Degradation Study on Stability Indicating RP-HPLC Method for Estimation of Stavudine and Zidovudine in Combined Dosage Form

For the simultaneous measurement of Stavudine and Zidovudine, a novel stability indicating reversed phase high- performance liquid chromatographic technique was created and effectively validated. Chromatographic separation was accomplished using an analytical column, which was kept at 30ºC. At a flow rate of 0.9 mL/min, a buffer (pH 4.6): acetonitrile (80:20) combination was used as the mobile phase. Stavudine and zidovudine were detected at a UV wavelength of 283 nm. Adequate separation of aged and stress-degraded Stavudine and Zidovudine stability samples proved the method's stability-indicating capacity. The International Conference on Harmonization (ICH Q2B) criteria were followed in determining several analytical performance characteristics, including system appropriateness, linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ), and robustness. For every analyte in the target concentration range, the calibration curves' linearity was excellent (r2>0.999).