Stability Indicating HPLC Method for Estimation of Thymoquinone in Nasal Simulated Fluid: Method Development and Validation

Introduction: A simple rapid and precise HPLC method was developed for estimation of TH in nasal simulated fluid stability assessed various stressed conditions.
 Methods: Chromatographic separation done using AS-4050 coupled with Jasco UV 2075 Plus detector, LC-Net 11/ADC valve, PU-2080 pump hypersil gold C18 (250x6x5 µm) column, ChromNAV 2.0 Chromatography Data System software mobile phase as acetonitrile: water (65:35) NSF (60:40) at a flow rate 1ml/min having run time 10 min loop volume 20 µl detection wavelength 252 nm. The validated accuracy, precision, linearity, specificity, sensitivity accordance ICH (Q2B) guidelines.
 Results: results all the validation parameters were found to be within acceptable limits. calibration plots linear over concentration ranges from 2 14µg/ml. accuracy precision between 97.04±0.112 to101.081±0.0191and ≤2% three drugs. Developed successfully applied determination recovery >98% degradation products produced result stress studies did not interfere drug peak.
 Conclusion: simple, specific, economic, reliable, accurate, precise, reproducible used quality control tool analysis pure thymoquinone fluid.