Naira Nayeem

A simple, accurate, rapid and precise isocratic High performance liquid chromatographic (HPLC) method was developed and validated for the quantification of betaine in Achyranthes aspera. The method employs Reversed Phase Phenomenex (US) C18 Column 250 x 4.6mm I.D, 5µ Particle Size system consisted of prominence LC-20AT gradient pumps, Prominence SIL- 20A Auto sampler and a Prominence SPD-M20A Diode Array Detector (SHIMADZU), Japan and flow rate of 1.0 ml/min with a load of 20μl. Water and acetonitrile was used as mobile phase in the composition of 10:90. The detection was carried out at 242 nm. Linearity range was 0.32-0.48 mg/ml. Retention time of betaine was found to 8.42 min. The recovery studies 98-103%. This method was validated for accuracy, precision, linearity and Robustness as per ICH guidelines. The method was found to be specific, selective, and robust.

The present work is simple and sensitive RP-HPLC Method Development and Validation for the simultaneous estimation of Metformin and Vildagliptin in bulk and its pharmaceutical dosage form and their Bio-Analytical studies. Chromatography was carried out on Kromosil C18 (4.6 x 250mm, 5mm) column using Phosphate buffer pH 5.8 and Acetonitrile in the ratio of 80:20 as the mobile phase at a flow rate of 1 ml/min with UV detection at 215 nm. The Retention time of Metformin and Vildagliptin is 2.589 mins and 4.296 mins respectively. The detector response is linear. The Limit of Detection for Metformin and Vildagliptin is 0.06 µg/ml and 0.1 µg/ml and Limit of Quantification for Metformin and Vildagliptin is 0.2 µg/ml and 0.4 µg/ml respectively. The Percentage assay for Metformin and Vildagliptin is 99.6% and 99.2% respectively and Percentage Recovery for average of three different concentrations for Metformin and Vildagliptin is 99.9% and 100.1% respectively. The method was validated by determining its selectivity, robustness, linearity, accuracy and precision. The developed method is simple, fast, sensitive, linear, accurate, rugged and precise and hence can be applied for routine quality control of Metformin and Vildagliptin in bulk and its pharmaceutical dosage form.