Abstract

METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN AND CLOPIDOGREL BISULFATE IN MARKETED FORMULATION USING HYDROTROPY PHENOMENA

Sourabh Dehariya*, Dr. Vimukta Sharma and Sayyed Mohsina

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Abstract

Method was developed and validated for the estimation of atorvastatin and clopidogrel bisulfate using hydrotropy phenomena. Firstly both standard drugs were characterized to check quality by melting point, solubility and FT-IR. The maximum absorbance of ATV and CLP was observed at 244.0 nm and 228.0 nm, respectively. ATV and CLP showed linearity in the concentration range of 5- - absorbance versus concentration. The overlain spectra also showed isoabsorptive points at 233.0 nm. Both drugs were estimated by using simultaneous equation method. Based on the solubility, stability and spectral characteristics of the drugs, 2M Sod. Citrate was selected as hydrotropic agent. Presence of hydrotropic agent do not shows any significant interference in the spectrophotometric assay thus further confirming the applicability and reproducibility of the developed method. Simultaneous equation method was validated by using different parameters like linearity, accuracy and precision. One marketed formulation was also estimated by novel developed method found 99.92 and 99.80 for ATV and CLP respectively.

Keywords: Simultaneous Estimation, Atorvastatin, clopidogrel bisulfate, hydrotropy phenomena.