Abstract
A simple, specific, accurate, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method and Stability indicating tests was developed and validated for the estimation of Ezetimibe and Glimepiride in Bulk drugs and pharmaceutical dosage forms. The Reverse phase chromatographic separation of Ezetimibe and Glimepiride was achieved on Inertsil C18 (250 x 4.6 mm; 5 μm) column using UV detection at 228 nm, the optimized mobile phase consisted of ACN: Phosphate Buffer (70:30) the flow rate was 1.4 ml / min. The retention time was found to be 3.921 ± 0.02min for EZET and 5.102 ± 0.02 min for GLIM. The method was validated as per ICH guidelines with respect to various parameters. The calibration curve showed linearity with correlation coefficient 0.997 for EZET & GLIM concentration range 60 -140 mcg & 6 -14 mcg and %RSD NMT 2 and LOD was found to be 3.09 μg / ml (EZET) and 0.23 μg / ml (GLIM) & LOQ was 9.37 μg / ml (EZET) and 0.69 μg / ml(GLIM) respectively. Recovery studies for EZET and GLIM was found to be in the range of 98.79% - 98.82%. The method developed was precise, accurate robust, rugged showing %RSD NMT 2.00. Then FD studies were conducted for both drugs in RP-HPLC the results showed that drugs are stable in all stress conditions. Hence all statistical data proves validity of the proposed methods and can be used for routine analysis of bulk drug and pharmaceutical dosage form.
