RP-HPLC Analytical Method of Metoclopramide Hydrochloride Prepared Nanoparticle formulation in Solid Oral Formulations by using Box-Behnken Design
Keywords:
RP-HPLC, Nanoparticles, Method Validation, Encapsulation Efficiency, Cumulative Drug ReleaseAbstract
An RP-HPLC method was developed and validated for the quantitative estimation of Metoclopramide Hydrochloride from both tablet dosage forms and optimized nanoparticle formulations. Chromatographic separation was achieved on a C18 column using a mobile phase of potassium dihydrogen phosphate buffer and methanol (60:40, v/v), with detection at 273 nm. The retention time for Metoclopramide Hydrochloride was found to be 6.78 minutes. The method was validated in accordance with ICH Q2 (R1) guidelines for specificity, accuracy, precision, linearity, robustness, and sensitivity. It exhibited excellent linearity across a wide concentration range, high recovery values, and low relative standard deviation, confirming reproducibility and reliability. In the nanoparticle formulation study, the optimized batch was selected based on a high desirability value of 0.9505, achieved at guar gum 2.99%, sodium alginate 2%, and chitosan 1.23%. The formulation showed an encapsulation efficiency of 93.87%, particle size of 180.63 nm, and cumulative drug release of 73.94%. The developed RP-HPLC method successfully quantified Metoclopramide Hydrochloride from these nanoparticles with results well within acceptable limits, confirming its applicability for routine analysis, stability evaluation, and potential pharmacokinetic studies involving nanoparticle-based drug delivery systems.
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