Development and validation of a new simple RP-HPLC method for estimation of Metformin HCl and Sitagliptin phosphate simultaneously in bulk and dosage forms (original) (raw)
Related papers
INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY, 2021
Reversed phase high performance liquid chromatography procedure was made and affirmed for the simultaneous estimation of Sitagliptin phosphate (SGP) and Metformin hydrochloride (MFH) in united estimation structure by using UV identifier. Picked adaptable stage was a blend of ACN: Methanol: Phosphate cradle (30:25:45 % v/v) at pH 3 and recurrence picked was 252 nm. Maintenance time of MFH and SGP is 2.36 and 3.39 min. Linearity of the strategy was viewed as 80% to 120% of test obsession with backslide coefficient of 0.9997. This technique was endorsed by ICH rules. Estimation was done by registering zone of the apex and beyond what many would consider possible and quantitation limit (S/N) were 0.16 and 0.46 μg/ml. Present strategy can be applied for the finishes of SGP and MFH in quality control tests, subtleties without impedance of the excipients present and in the breaking down examinations of the medicine.
International Journal of PharmTech ResearchVol.5, No.4, pp 1736-174, Oct-Dec 2013, 2013
A simple, accurate, specific and reliable RP-HPLC method for the simultaneous estimation of Sitagliptin Phosphate and Metformin Hydrochloride in Pharmaceutical dosage form was developed and validated according to currently accepted ICH guidelines of analytical method validation. In the present method, SHIMADZU HPLC with UV detector LC 10 AT VP with analytical column PHENOMENEX Luna (C18) A 100 RP Column, 250 mm x 4.6 mm x 5μm, an injection volume of 20µl was injected and eluted with mobile phase 0.02M Potassium dihydrogen phosphate pH(4.0) : Acetonitrile (60:40) pumped at a flow rate of 1.0ml/min. Sitagliptin Phosphate and Metformin Hydrochloride were eluted at 2.718 and 1.925 min. The detection was carried out at a wavelength 252nm. The method was validated for system suitability, linearity, accuracy, precision and robustness of sample solution. The linear ranges for Metformin Hydrochloride and Sitagliptin Phosphate were 20-120μg/mL, 2-12μg/mL respectively with good recoveries i.e. 99.4% to 101.35%.
2013
Sitagliptin phosphate and metformin are used widely in lowering the blood glucose levels, and it is proved to be safe when used in combination. There is no analytical method yet reported for the simultaneous estimation in this combination. Therefore the present study has been undertaken in order to develop new, simple, rapid, efficient and reproducible method for the analysis of sitagliptin phosphate and metformin with new solvent. Objectives: To develop a method for the combination of sitagliptin phosphate and metformin in tablet dosage form by RP-HPLC and to validate the developed RP-HPLC method Methodology: Simultaneous Estimation of Sitagliptin and Metformin by RP-HPLC. Results & Discussion: Assay was determined in terms of the peak areas of a set of drug solutions on the same day were calculated in terms of percentage relative standard deviation. Binary mixture of Buffer and Acetonitrile (50:50 v/v) proved to be better than the mixture of other combinations. Among several flow rates tested (0.5 to 2 ml per min), the flow rate of 1 ml/min was the best with respect to retention and resolution of analytical peaks. A detecting wavelength at 256 nm showed better selectivity, no interfering peaks were found indicating that the in the tablet dosage form. Conclusion: The proposed HPLC method was validated by evaluation of the validation parameters. The LOD, LOQ values, relative standard deviation of slope, correlation coefficient, within and between day reproducibility, resolution and tailing factors for this technique were obtained. The results obtained were reproducible and reliable.
2013
A few methods are available for routine analysis of sitagliptinphosphate and metformin hydrochloride. Here we have developed a simple, precise and stability-indicating HPLC method and validated for the simultaneous determination of sitagliptinphosphate and metformin hydrochloride in pharmaceutical dosage form.The method involves the use of easily available inexpensive laboratory reagents. The method was carried out on a Supelco Column (25cm×4.6mm i.d; particle size 5-microns) with a mobile phase consisting of (70:30 v/v Acetonitrile: ammonium acetate buffer) at a flow rate of 0.8 ml/min.The retention time of the sitagliptin and metformin was about 6.54 and 4.24mins respectively. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The described method was linear over a concentration range of 10-50 μg/ml and 1-5 μg/ml for the assay of metformin and sitagliptin respectivelywith a correlation coefficient of 0.999.The accuracy (rec...
2012
A new simple and precise reverse phase high performance liquid chromatographic method has been developed and subsequently validated for the simultaneous estimation of Metformin and Sitagliptin in combination. The chromatographic separation was performed in Waters equipment using mobile phase consisting of Potassium dihydrogen orthophosphate: Methanol in the ratio of 50:50 and the pH -4 adjusted by orthophosphoric acid. The column used was Hypersil BDS C 18, 5μ, 150mm x 4.6 mm internal diameter with flow rate of 1 ml/min using PDA detection at 260 nm. The retention time was found to be 1.773 min for Metformin and 3.696 min for Sitagliptin .The described method was found to be linear and correlation coefficient was 0.999. Results of analysis were validated statistically and by recovery studies. Precision were performed as per ICH guidelines with the result shows relative standard deviation not more than 2%. The assay value for Metformin and Sitagliptin were found to be 99.89% and 99.9...
International Journal of Medical and Biomedical Studies
A novel approach was used to develop and validate a rapid, specific, accurate and precise Reverse phase High performance liquid chromatographic (RP-HPLC) method for the simultaneous determination of Metformin and Sitagliptin in pharmaceutical dosage forms and its applications to dissolution study. The chromatographic separation was carried out on a C8 (250mm X 4.6 mm i.d., 5μm) column with a mobile phase of 40 Acetonitrile: 60 Phosphate Buffer (pH 6.8), using UV detector at 257 nm at 1ml min-1 flow rate. The retention time for Metformin was 2.11 minutes and 5.30 minutes for Sitagliptin. The Linearity for Metformin was found to be 10-80 µg ml-1 with R2 value of 0.9998 and for Sitagliptin 1-8 µg ml-1 with R2 value of 0.9976. Dissolution study of both for Metformin and Sitagliptin was carried, Percentage of drug release was established which was found to be 96.23% and 102.64% respectively, in the period of 50 minutes. Keywords: RP-HPLC, Metformin, Sitagliptin, Dissolution study
A new RP-HPLC method for the quantitative determination of Metformin and Sitagliptin was developed and validated as per ICH guidelines. The drugs were injected into Kromasil C18 (4.6 x 250mm, 5µm), maintained at ambient temperature and effluent monitored at 254 nm.The mobile phase consisted of OPA (0.1%) : Acetonitrile (40% : 60%) The flow rate was maintained at 1.0 ml/min. The calibration curve for Metformin and Sitagliptin were linear from 125-7500µg/ml and 12.5-75µg/ml respectively (r 2 for Metformin = 0.999,r 2 for Sitagliptin = 0.999).The proposed method was adequate, sensitive, reproducible, accurate and precise for the determination of Metformin and Sitagliptin in bulk and tablet dosage form.
International Journal of ChemTech Research, 2018
RP-HPLC method have been Development and Validation For Simultaneous Estimation for Metformin And Sitagliptin in Bulk and Tablet Formulation was developed using Grace C18 column(250nm x 4.6ID, Particle size: 5 Micron) as stationary phase and methanol : HPLC grade water (80:20%v/v, pH3.0) as mobile phase was maintained at a flow rate of 0.8ml/min, the retention time of Metformin And Sitagliptin were found to be 6.19 min and 7.42 min and detection was carried out at 254nm. The high recovery and low coefficients of variation confirm the suitability of the method for simultaneous analysis of the Sitagliptin and Metformin in bulk and tablet Formulation. The validated method was successfully used for quantitative analysis of Janumet tablet.