Development and Validation of a Simple Method for Simultaneous Estimation of Metformin Hydrochloride and Gliclazide in Tablets by using Reversed Phase High Performance Liquid Chromatography (original) (raw)
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Journal of Scientific Research, 2013
A rapid and sensitive isocratic reversed phase high performance liquid chromatographic method has been developed for quantitative analysis of metformin hydrochloride and gliclazide in bulk as well as pharmaceutical dosage forms. The method was validated according to FDA, ICH and USP guidelines with respect to accuracy, precision, specificity and linearity. For metformin, the method was developed by using the mobile phase comprising of sodium dihydrogen phosphate solution (NaH 2 PO 4) (pH 3.0) and acetonitrile (90:10, v/v) at a flow rate of 0.5 mL/min over C 18 bonded silica column (3.9 x 300 mm, 5 µm) at ambient temperature. On the other hand, the same mobile phase was used in the ratio of 20:80 (v/v) at a flow rate of 0.6 mL/min for gliclazide. The recovery was found to be more than 97% for metformin and 102% for gliclazide that demonstrated the accuracy of the protocol. Intraday and interday precisions of the new method were less than the maximum allowable limit (%RSD 2.0) specified by the USP, ICH and FDA. The method revealed linear response with correlation coefficient value of 0.999 in both cases.
2012
A new simple fast economical reverse phase high performance liquid chromatographic method was developed for the determination of Metformin Hcl [MFH] and Gliclazide [GZ] in bulk and dosage form. The separation was eluted on a RP-Select B C18 column (250 mm x 4.6 mm; 5μ) using a mobile phase mixture of phosphate buffer and acetonitrile in a ratio of 60:40 v/v at a flow rate of 1.0ml/min. The detection was made at 261 nm. The retention times were 3.26min for [MFH] and 6.07min for [GZ]. Calibration curve was linear over the concentration range of 125-750 μg/ml for (MFH) and 20 to 120 μg/ml for [GZ]. The propose method was validated as per the ICH guidelines parameters like Linearity, specificity, precision, accuracy, robustness and ruggedness. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.
International Journal of Pharmaceutical Chemistry, 2014
A simple precise reproducible U.V. Spectrophotometric method have been developed and validated for the simultaneous estimation of MET and GPZ in tablet dosage form. This paper describes the simultaneous equation method as a quantification parameter which involves the measurement of absorbance of MET and GPZ at 237 nm and 234.0 nm respectively. MET and GPZ both obeyed linearity in the range of 2?g/mL to 20 ?g/mL. The recovery studies shows %RSD for MET 0.005, 0.12, 0.65 and for GPZ 0.008, 0.54, 0.25 by SEM method. The results of analysis have been validated statistically for accuracy, Precision, Repeatability, and Ruggedness. The method was successfully applied to the determination of these drugs in pharmaceutical dosage form
Journal of Food and Drug Analysis, 2019
An efficient and simple HPLC method has been developed and validated for the simultaneous determination of gliclazide and metformin hydrochloride in bulk and was applied on marketed metformin and gliclazide products. The mobile phase used for the chromatographic runs consisted of 20 mM ammonium formate buffer (pH 3.5) and acetonitrile (45:55, v/v) The separation was achieved on an Alltima CN (250 mm  4.6 mm x5m) column using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 227 nm. The method was linear at the concentration range 1.25e150 mg/ml for gliclazide and 2.5e150 mg/ml for metformin respectively. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Metformin limit of detection (LOD) and limit of quantification (LOQ) were 0.8 mg/ml and 2.45 mg/ml respectively while LOD and LOQ for gliclazide were 0.97 mg/ml and 2.95 mg/ml respectively.
A stability indicating RP-HPLC method was developed and validated for the determination of Metformin HCl and Glimepiride in tablet dosage form. The method was carried out using Agilent C18 column (250 mm×4.6 mm, 5 μ) with mobile phase consisting 25 mM Hexane-1-sulphonic acid buffer adjusted to pH 2.5 with ortho-phosphoric acid and acetonitrile (45:55 v/v), at a flow rate of 1.0 mL/min and the effluent monitored at 229 nm. The retention time of Metformin HCl and Glimepiride were found to be 3.55 0.5 and 5.82 0.5 min respectively. Linearity was observed over the concentration range of 150-750 µg/mL for Metformin HCl and 0.75-4.5 µg/mL for Glimepiride. The percentage recoveries of Metformin HCl and Glimepiride in the marketed dosage form found to be 101.6 and 99.9 respectively. The reliability and analytical performance of the proposed method were statistically validated for specificity, linearity, precision, accuracy, and ruggedness, detection, and quantification limits. The drug was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and humidity degradation. The drug is more sensitive towards oxidation degradation. The method was validated as per ICH guidelines.
Journal of Liquid Chromatography & Related Technologies, 2012
A simple, rapid, and specific reversed-phase high performance liquid chromatographic method for simultaneous estimation of Metformin hydrochloride (MET) and Repaglinide (RPG) in a tablet dosage form has been developed and validated. HPLC analysis was performed on a C 18 column with 90:10 (v/v) acetonitrile-water as mobile phase at a flow rate of 1.0 mL min−1. UV detection was performed at 223 nm. Total run time was 10 min; Metformin hydrochloride and Repaglinide were eluted with retention times of 2.72 min and 6.13 min, respectively. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines. Validation revealed that the method is specific, rapid, accurate, precise, reliable, and reproducible. The high recovery and low coefficients of variation confirmed the suitability of the method for simultaneous analysis of the two drugs in tablet dosage form.
Journal of Pharmaceutical Research, 2017
Purpose : A simple, sensitive, linear, precise, and accurate method by gradient reversed-phase-high performance liquid chromatography for the simultaneous estimation of metformin (MET), losartan (LOS) and glimepiride (GLI) in bulk and in their combined tablet dosage form was developed and validated. Methodology : The separation of the three drugs was based on the use of Luna c18 (250 ~ 4.6 mm, i.e. 5 ƒEm) column in a gradient mode. Mobile phase consisted of Methanol (solvent A) and 0.1% Orthophosphoric acid [OPA] (solvent B) was set with gradient programming for 18 min and was delivered at 1 ml/min flow rate and effluents are achieved with variable wavelength: Photodiode array detector at 284 nm. The retention times of MET, LOS and GLI were found to be 3.11, 7.12 and 13.52mins respectively. The percentage assay of MET, LOS and GLI was found to be 100.5%, 100.5 and 100.4%, respectively. Calibration curves were linear for MET, LOS and GLI at concentration ranges of 30- 450 ng/ml, and...
2004
Department of Chemistry, University of Allahabad, Allahabad-211 002, India <em>Manuscript received 10 October 2002, revised 4 June 2003, accepted 4 July 2003</em> A new HPLC method for the determination of Glipizide and Metformin hydrochloride in combination has been described. The method is based on reverse phase liquid chromatography using C-18 column and a suitable moblie phase. The detection is done at 225 nm. The flow rate is adjusted at 1.0 ml/min and linearity is established.
Current Pharmaceutical Analysis, 2012
A simple stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Cabazitaxel in infusion forms. Reversedphase chromatography was performed on Shimadzu Model CBM-20A/20 Alite, using a mixture of Phosphate buffer and Acetonitrile (30:70, v/v) as mobile phase with a flow rate of 1.0 mL/min. Detection was carried at 230 nm. Linearity was observed over the concentration range of 0.1-150 μg/mL (R 2 = 0.9999) with regression equation y = 28290 x + 7032.3. Cabazitaxel was subjected to stress conditions (acidic, alkaline, oxidation, UV and thermal degradation) and validated as per ICH guidelines.