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Validated And Stability Indicating Of Rp-Hplc Method For Simultaneous Estimation Of S(-)Metoprolol Succinate & Clopidogrel Bisulfate In Bulk And Tablet Dosage Form


 

A simple, selective, accurate, and sensitive High Performance Liquid Chromatographic (HPLC) method was developed and validated for the simultaneous analysis of S(-)Metoprolol succinate(MS) & Clopidogrel bisulfate(CB). Chromatographic separation achieved isocratically on a Hypersil BDS C8 (250mm X 4.6mm, 5µm) column utilizing a mobile phase of Methanol: Acetonitrile: Buffer (15:40:45) v/v , (pH 4.5 with OPA) at a flow rate of 1.5 mL / min and column oven temperature 40o C with PDA detection at 220 nm. Statistical analysis proves that the method is reproducible and selective for the simultaneous estimation of MS and CB.Stability indicating studies shows both drugs are stable in oxidative stress condition and light. Metoprolol Succinate under goes degradation in both acidic and basic conditions but up to less extent than Clopidogrel bisulfate. The developed method was validated as per ICH guidelines in terms of accuracy, precision, linearity and specificity. Thus the study aimed at developing and validating new HPLC method, being simple, accurate, selective and sensitive and can be applied for the estimation of these drugs in combined dosage form

 


Keywords

S(-)Metoprolol succinate, Clopidogrel bisulfate, RP-HPLC, Validation
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  • Validated And Stability Indicating Of Rp-Hplc Method For Simultaneous Estimation Of S(-)Metoprolol Succinate & Clopidogrel Bisulfate In Bulk And Tablet Dosage Form

Abstract Views: 124  |  PDF Views: 0

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Abstract


A simple, selective, accurate, and sensitive High Performance Liquid Chromatographic (HPLC) method was developed and validated for the simultaneous analysis of S(-)Metoprolol succinate(MS) & Clopidogrel bisulfate(CB). Chromatographic separation achieved isocratically on a Hypersil BDS C8 (250mm X 4.6mm, 5µm) column utilizing a mobile phase of Methanol: Acetonitrile: Buffer (15:40:45) v/v , (pH 4.5 with OPA) at a flow rate of 1.5 mL / min and column oven temperature 40o C with PDA detection at 220 nm. Statistical analysis proves that the method is reproducible and selective for the simultaneous estimation of MS and CB.Stability indicating studies shows both drugs are stable in oxidative stress condition and light. Metoprolol Succinate under goes degradation in both acidic and basic conditions but up to less extent than Clopidogrel bisulfate. The developed method was validated as per ICH guidelines in terms of accuracy, precision, linearity and specificity. Thus the study aimed at developing and validating new HPLC method, being simple, accurate, selective and sensitive and can be applied for the estimation of these drugs in combined dosage form

 


Keywords


S(-)Metoprolol succinate, Clopidogrel bisulfate, RP-HPLC, Validation