Novel RP-HPLC Method Development and Validation of Meloxicam Suppository

Abstract:

Objective: A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Meloxicam drug (MLX) in pharmaceutical mixture. Methods: Effective chromatographic separation achieved using a phenomenex luna C₁₈ (4.6 mm, 250 mm, 5 μm) column with isocratic elution by the mobile phase composed of 0.02 M Potassium dihydrogen orthophosphate, pH adjusted to 4 with orthophosphoric acid (filtered): acetonitrile (50:50) respectively. The flow rate is 1.0 ml/min on detecting wavelength 220 nm. Results: The proposed HPLC method was statistically validated with respect to linearity, ranges, precision, accuracy, selectivity, LOD, LOQ and robustness. The retention time (RT) of Meloxicam was found to be 6.0 min. respectively. All parameters were found to be within the acceptance limit. The calibration curve was linear in ranges of 3-6, 6-9, and 15-18 mg/ ml for Meloxicam. The R² of Meloxicam was found to be 0.996 respectively. Conclusion: A novel simple, simple, sensitive, precise, rapid, accurate and economical and reliable RP-HPLC method was developed and validated for the Meloxicam suppository.

Key words: Meloxicam, RP HPLC, Method Development, Validation, Suppository, Novel.