Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR THE DETERMINATION OF ASPIRIN AND DOMPERIDONE IN BULK AND COMBINED DOSAGE FORM

*Afiya Khan, Dr. Mohd. Jalaluddin, Mrs. Sheenam Mansuri, Dr. Brajesh Kumar Arjariya and Mr. Rahim Khan

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Abstract

The aim of present study was to investigate the development and validation of Stability Indicating Assay Method for the determination of aspirin and domperidone. Method Development and Validation for Estimation of Domperidone and Aspirin in bulk or formulation by using RP-HPLC. The RP-HPLC method was developed for estimation of Aspirin and Domperidone in synthetic mixture by isocratically using 10 mM KH2PO4: Acetonitrile (20:80) as mobile phase, Prontosil C-18 column (4.6 x 250 mm, 5μparticle size) column as stationary phase and chromatogram was recorded at 231 nm. Then developed method was validated by using various parameters such as, linearity, Range accuracy, precision repeatability, intermediate precision, robustness, limit of detection, limit of quantification. The proposed methods were found to be linear with correlation coefficient close to one. Precision was determined by repeatability, Intermediate precision and reproducibility of the drugs. The robustness of developed method was checked by changing in the deliberate variation in solvent. The result obtained shows the developed methods to be Cost effective, Rapid (Short retention time), Simple, Accurate (the value of SD and % RSD less than 2), Precise and can be successfully employed in the routine analysis of these drugs in bulk drug as well as in tablet dosage form. The Simplicity, Rapidly and Reproducibility of the proposed method completely fulfil the objective of this research work.

Keywords: Aspirin; Domperidone; HPLC; Ultra Violet; Validation.