Analytical Method Development and Validation of Metformin, Voglibose, Glimepiride in Bulk and Combined Tablet Dosage Form by Gradient RP-HPLC

Abstract

Background: A simple, sensitive, linear, precise, and accurate method by gradient reversed-phase-high performance liquid chromatography for the simultaneous estimation of metformin (MET), voglibose (VOG) and glimepiride (GLI) in bulk and in their combined tablet dosage form was developed and validated. Materials and Methods: The separation of the three drugs was based on the use of Inertsil ODS 3V (150 × 4.6 mm, i.e. 5 μm) column in a gradient mode. Mobile phase consisted of 0.02 M Phosphate buffer adjusted to pH 2.5 using dilute orthophosphoric acid (solvent A) and acetonitrile (solvent B) was set with gradient programming for 18 min and was delivered at 1 ml/min fl ow rate and effl uents are achieved with variable wavelength: Photodiode array detector at 230 nm. Results: The retention times of MET, VOG and GLI were found to be 2. 423, 8.191, and 11.708, respectively. The percentage assay of MET, VOG and GLI was found to be 99.92%, 99.32, and 99.72%, respectively. Calibration curves were linear for MET, VOG and GLI at concentration ranges of 200-600 μg/ml, 0.08-0.24 μg/ml, and 0.8-2.4 μg/ml with the regression coeffi cient of 0.999 for all the three drugs and precise with (% relative standard deviation <2). The limit of detection for MET, VOG and GLI was found to be 0.05 μg/ml, 0.004 μg/ml, 0.002 μg/ml, and limit of quantitation for MET, VOG and GLI was found to be 1.5 μg/ml, 0.012 μg/ml, and 0.006 μg/ml, respectively. Conclusion: The method was validated by determining its linearity, accuracy, precision, system suitability and can be employed for routine quality control analysis as per International Conference on Harmonization guidelines.

Development and Validation of Stability-Indicating Simultaneous Estimation of Metformin and Alogliptin in Tablets by High-Performance Thin Layer Chromatography

“…The results of the analysis of the marketed formulation are given in table 2. [4][5][6][7][8] the spots of degradation products were well resolved from those of the drugs. The peaks of the metformin and alogliptin were not significantly shifted in the presence of the degradation peaks, which indicated the stabilityindicating the nature of the method.…”

“…2, respectively. Literature survey reveals that spectrophotometric [3][4][5], High-Performance Liquid chromatography [HPLC] [6][7][8] and high-performance thin-layer chromatography [HPTLC] [9][10][11] methods for the estimation of metformin alone or in combination with other drugs from pharmaceutical formulation have been developed whereas spectrophotometric [12][13][14], RP-HPLC [15][16][17], HPTLC [18] and LC-MS/MS [19] methods for the estimation of alogliptin alone or in combination with other drugs from pharmaceutical formulation have been developed. However, no stability-indicating method has been reported so far simultaneous estimation of both drugs in combined pharmaceutical dosage form by HPTLC.…”

Analytical Quality by Design Assisted HPLC Method for Quantification of Canagliflozin/ Metformin and Stability Studies

“…Several analytical methods such as spectrophotometric, HPLC, HPTLC and UPLC which have been reported for analysis of canagliflozin [2][3][4][5][6] and metformin [7][8][9][10] in an entity or combination with other drugs. [11][12][13][14] Few UV, HPLC, stability-indicating and bioanalytical methods were also reported for estimation of metformin hydrochloride and canagliflozin, simultaneously. [15][16][17][18][19][20][21][22] The reported conventional chromatographic methods were monotonous and concerned with time consuming process of varying one factor at a time (OFAT), require large number of experimental runs and always yields a narrow robust method which has high risk of failure during transfer/ real-time usage.…”

Development and Validation of New Stability Indicating Reversed-Phase High-Performance Liquid Chromatography Method for Simultaneous Determination of Metformin Hydrochloride and Ertugliflozin in Bulk and Pharmaceutical Dosage Form

“…Even though numerous methods are available for the estimation of metformin hydrochloride individually and in combination with other drugs, no method has been reported for the estimation of metformin hydrochloride and ertugliflozin simultaneously [6][7][8][9][10][11][12][13][14][15][16].…”