A VALIDATED ANALYTICAL METHOD FOR RANITIDINE HCL THROUGH LC-MS/MS, HPLC AND QUALITY BY DESIGN APPROACH.
DOI:
https://doi.org/10.22159/ijap.2025v17i6.55652Keywords:
Analytical method development, Method validation, ICH, Ranitidine HCl, QbDAbstract
Objective: The current study aimed to develop and validate simple, precise, and highly sensitive LC-MS/MS and HPLC methodologies for the quantitative estimation of Ranitidine HCl in pharmaceutical formulations. The goal was to develop a speedy and dependable technique for routine quality control and regulatory analysis.
Methods: Chromatographic separation was achieved using an Atlantis C18 column (150×4.6 mm, 5µm) under isocratic elution mode. The mobile phase consisted of 10 mmol ammonium acetate (solvent A) and acetonitrile (solvent B) in a 10:90 v/v ratio, delivered at a flow rate of 0.7 ml/min. An injection volume of 10µl* was employed, and the run time was 4 min. Ranitidine HCl was eluted at 1.993 min. The method was validated in accordance with ICH Q2 (R1) guidelines for parameters including linearity, sensitivity, accuracy, precision, and robustness.
Results: The LC-MS/MS method showed excellent linearity across a concentration range of 5-250 ng/ml with a correlation coefficient (R2) of 0.9998. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 1.0 ng/ml and 3.0 ng/ml, respectively. Recovery ranged from 95.33% to 97.93% and relative standard deviation (RSD) was 0.69%, confirming the method’s accuracy and precision.
Conclusion: The validated LC-MS/MS and HPLC methods are simple and sensitive for the quantification of ranitidine HCl. Both techniques demonstrated robust performance with high accuracy and precision. Their successful application to a commercial formulation confirms their suitability for pharmaceutical quality control and supports regulatory compliance in the routine analysis of ranitidine HCl products.
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