Metformin

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 purpose of this research work was to formulate an anti-diabetic in a single dosage form i.e. Metformin HCl in sustained release layer and Miglitol in immediate release layer of the bilayer tablet. The tablets were prepared using Hydroxypropyl methylcellulose (HPMC K4M & HPMC K15M, sodium alginate and xantham gum) an as release retarding polymers in various combination and concentrations. The effect of different super disintegrants on immediate release in various concentrations was also studied. Eight formulations of immediate release layer were prepared using SSG and CCS super disintegrants with different proportions and were evaluated for different parameters. Among the eight formulations M4 containing CCS as disintegrant showed a better release of 95.50±0.15% for 30 mins was selected. Using this MT4 formulation eight formulations of sustained release layer of Metformin. HCL was prepared with HPMC k15M polymer and evaluated. Among nine formulations of bilayered tablets MM4 was showed 98.66±0.65% at the end of 8 hrs. was selected as optimized formulation.  This optimized formulation was evaluated for parameters like, thickness, hardness, friability, weight variation, drug content, in vitro   drug release and stability and results were found to be with in  USP limits.

A simple, rapid, accurate and precise high performance thin-layer chromatography (HPTLC) method was developed and validated for simultaneous estimation of alogliptin and metformin active pharmaceutical ingredients and fixed dose combination. Alogliptin and metformin densitograms were developed on silica gel 60 F254 HPTLC plates with chloroform: methanol: 0.5 % ammonium sulphate (4:4:2 %v/v) as mobile phase. Densitometric quantification was performed at 254 nm. For Alogliptin and Metformin Rf values were found as 0.66 and 0.44, respectively. The linearity curves of Alogliptin and Metformin were obtained in the concentration range of 100-500 ng/spot and 4000-20000 ng/spot by area with correlation co-efficient of 0.998 and 0.995 for Alogliptin and Metformin, respectively. Limit of detection was found to be 2 ng and 40 ng/spot for Alogliptin and Metformin, respectively; lowest possible quantity to be quantified by the proposed method was found to be 6 ng and 130 ng per spot for Alogliptin and Metformin, respectively. The method was validated for precision, accuracy, specificity and robustness. The developed method was validated and found to be selective, specific and suitable for application in pharmaceutical analysis of these drugs in bulk and fixed dose combination.

Over the last decade, diabetes mellitus has emerged as an important clinical and public health problem throughout the world. The aim of the study is   perceive the Potentiality of a newer oral Antihyperglycemic combination therapy over conventional therapy in type 2 diabetes. The prospective study was conducted over a period of six months in the department of Medicine, Guntur City Hospital. The prevalence of type2 diabetes was high in male 65.79 % than female 34.21%. Majority of the patients  (23.68 %) belonged to age group of 51–55 years. Majority of patients (55.26%) having a family history of Diabetes. Majority of patients receiving Combination of Glibenclamide + Metformin (60.53%), evaluated for effect on FPG for both combinations. The mean changes in FPG were noted. In the same way effect on HbA1c also noted. Mean changes in for every month HbA1c will be noted. Our study reveals that Combination therapy with Metformin plus Glimepiride is more effective than Glibenclamide plus Metformin; in improving glycemic control in type 2 diabetes, while also allowing a reduction of the dosage of each drug.

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 aim of this investigation was to develop and optimize Metformin HCl matrix tablets for sustained release application by response surface methodology based on two factor-three response factorial design. The effects of the amounts of polysaccharide from tamarind and polysaccharide from jackfruit in Metformin HCl matrix tablets on the properties of Metformin HCl sustained release matrix tablets drug release was analyzed and optimized. The observed responses were coincided well with the predicted values by the experimental design. The optimized Metformin HCl matrix tablets showed prolonged sustained release of Metformin HCl over 6 hours. These matrix tablets followed the first-order model with anomalous (non-Fickian) diffusion mechanism.

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 new simple, accurate, precise and reproducible Reverse Phase-High Performance Liquid Chromatography  method has been developed for the simultaneous estimation of Sitagliptin and Metformin in bulk and pharmaceutical dosage form using Symmetry C18 column (4.6 x 150mm, 3.5mm, Make: XTerra) in isocratic mode. The mobile phase has been prepared by using Potassium Dihydrogen Phosphate and Acetonitrile in different ratio at different pH. Several trials have been performed and it was found that ratio 0f 65:35 of Potassium Dihydrogen Phosphate and Acetonitrile respectively was shown a good peak at pH 5.8 which has been adjusted by using Sodium Hydroxide. The detection was carried out at 254 nm. The method was linear over the concentration range for Sitagliptin 10-30ppl and for Metformin 100-300ppm. The % recoveries of Sitagliptin and Metformin were found to be 99.1 to 100.6% and 98.8 to 100.7% respectively. The validation of method was carried out utilizing International Conference on Harmonization (ICH) guidelines. The described High Performance Liquid Chromatography method was successfully employed for the analysis of pharmaceutical formulations containing combined 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.

  In the present research a simple, accurate, precise and cost effective UV-Vis spectrophotometric method for the estimation of Metformin, in bulk and pharmaceutical dosage form was illustrated. The absorption maxima of the drug was found to be 233 nm in 0.1 N HCl: Distilled water (27:75). A linear response was observed in the range of 5-10 µg/ml with a regression coefficient of 0.999. Validation parameters were carried out as per the guidelines of International Conference for Harmonization. This method can be used in the industries for determination of Metformin to analyze the quality of formulation without interference of the excipients.