Abstract
A simple, precise, rapid, selective, and economic reversed phase high-performance liquid chromatography (RPHPLC) method has been established for simultaneous analysis of Metformin hydrochloride and Rosuvastatin in bulk powder and In-House Formulation on a Phenomenex C18 (250×4.6 mm i.d) chromatographic column equilibrated with mobile phase containing Acetonitrile/0.02 M Sodium dihydrogen o-phosphate. Experimental conditions such as pH of mobile phase, ratio of organic phase, flow rate, wavelength, etc. were critically studied and the optimum conditions were selected. Efficient chromatographic separation was achieved with mobile phase containing combination of Phosphate buffer pH 2.8 and Acetonitrile in ratio of 65:35(v/v) adjusted to pH 3.8 at flow rate of 1.0 ml/min and eluents were monitored at 252 nm. 20 μl of sample was injected into chromatographic system and the total run time was 10 min. The retention time for Metformin and Rosuvastatin were 2.147 min and 3.80 min respectively. The method was linear in the range of 5μg mL-1to 30μg mL-1and 0.4 μg mL-1to2.4μg mL-1for Metformin and Rosuvastatin respectively. The proposed method was successfully applied to the analysis of Metformin and Rosuvastatin in bulk and in-house formulation without interference from other additives. The developed method was validated according to ICH guidelines. Linearity, regression value, recovery and % RSD of intra and interday precision values were found within the limits and the method was found to be satisfactory. This validated HPLC procedure is economic, sensitive, user-friendly and less time consuming than other chromatographic procedures.
Highlights
A simple, precise, rapid, selective, and economic reversed phase high-performance liquid chromatography (RPHPLC) method has been established for simultaneous analysis of Metformin hydrochloride and Rosuvastatin in bulk powder and In-House Formulation on a Phenomenex C18 (250×4.6 mm i.d) chromatographic column equilibrated with mobile phase containing Acetonitrile/0.02 M Sodium dihydrogen o-phosphate
The combination of Rosuvastatin and Metformin complement each other and provides reduction in plasma cholesterol along with glycemic control thereby providing a comprehensive control of diabetes and associated dyslipidemia (Figures 1 and 2)
Rosuvastatin was estimated in body fluids and in pharmaceutical formulations by spectrophotometry, HPLC methods and resonance light scattering technique [7,8,9]
Summary
A simple, precise, rapid, selective, and economic reversed phase high-performance liquid chromatography (RPHPLC) method has been established for simultaneous analysis of Metformin hydrochloride and Rosuvastatin in bulk powder and In-House Formulation on a Phenomenex C18 (250×4.6 mm i.d) chromatographic column equilibrated with mobile phase containing Acetonitrile/0.02 M Sodium dihydrogen o-phosphate. Experimental conditions such as pH of mobile phase, ratio of organic phase, flow rate, wavelength, etc. No method was described for the simultaneous estimation of these drugs in bulk or laboratory prepared mixtures. an attempt was madeto develop a simple, accurate isocratic HPLC method for simultaneous determination of Metformin and Rosuvastatin in bulk and In-House formulation
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