Vildagliptin

This study reports the method development and validation for anti-diabetic drugs by UPLC.  A new, simple, rapid, selective, precise and accurate ultra performance liquid chromatography assay has been developed for simultaneous estimation of Remogliflozin, Vildagliptin and Metformin. The separation was achieved by using ODS 3V column with dimensions 5 µm, 4.6 mm x 250 mm. The pH of mobile phase was adjusted to 4.5 with acetonitrile. The flow rate was 0.4 mL/min, and the separated drugs were detected using UPLC detector at the wavelength of 260 nm. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent. It was successfully applied for the analysis of these drugs in marketed formulations and could be effectively used for the routine analysis of formulations.

The primary objective of this study is to investigate the potential of Lannea coromandelica gum (LCG) and Terminalia catappa gum (TCG) as agents to slow down the release of Vildagliptin in the development of once-daily matrix tablets. Both LCG and TCG are refined exudates obtained from their respective trees using established methods. To determine any interactions between the gums and the drug, Fourier transform infrared spectroscopy studies were conducted. Matrix tablets of Vildagliptin were created using these gums through the wet granulation technique. The granules were subjected to assessment for parameters such as angle of repose, bulk density, and compressibility index, which indicated favorable flow properties. The resulting tablets were then subjected to various quality control tests, including weight variation, hardness, and friability. All Vildagliptin matrix tablets exhibited uniform weight and drug content, with low standard deviation values. Dissolution studies confirmed that LCG and TCG can be employed as materials for forming the matrix in extended-release tablets. Kinetic release data analysis revealed that most of the solid matrix formulations conformed to Higuchi or zero-order kinetics.

A simple, rapid, sensitive, reversed phase-HPLC method was developed and validated to measure simultaneously the amount of Metformin and Vildagliptin at single wavelength (210 nm) in order to assess quantification in its tablet formulation and its subsequent stability studies. An isocratic elution of filtered sample was performed on Hypercil BDS C18 column with buffered mobile phase (0.1 M potassium dihydrogen ortho Phosphate buffer (Ph 4.8) and acetonitrile in the ratio of 60:40 v/v) with Hypercil BDS detection at 210 nm. The linearity for concentrations between 12.5μg/ml–75μg/ml for Metformin and 1.25μg/ml – 7.5μg/ml for Vildagliptin were established.  The limits of detection (LOD) and quantification were 1.75 and 5.29 µg/ml for metformin and 0.46 and 1.39 µg/ml for vildagliptin. The determination of the two active ingredients was not interfered by the excipients of the products. This method was satisfactorily applied to the analysis of the tablet formulations and proved to be specific and accurate for the quality control of the cited drugs in tablet dosage form.

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.

A simple, accurate, precise and reproducible method has been developed for the simultaneous estimation of Vildagliptin and Metformin hydrochloride in combined tablet dosage forms. As there are no reported UV methods for the simultaneous estimation of Vildagliptin and Metformin hydrochloride in their combined dosage form, a need was felt to develop new methods to analyze the drugs simultaneously. The estimation was done by multi-wavelength technique, at wavelengths of 217 nm and 234 nm over the concentration ranges of 0.7µg/ml and 7 µg/ml with mean recovery 100% for both drugs Vildagliptin and Metformin hydrochloride respectively. The results of the analysis were validated statistically and recovery studies were carried out as per ICH guide lines. Thus the proposed method can be successfully applied for the simultaneous estimation of Vildagliptin and Metformin hydrochloride in routine analysis work.