Development, Computational Studies and Validation of Spectrophotometric Method of Metformin Hydrochloride in Pharmaceutical Formulations

Judeh, Ahmed Abu; Sarief, Abdulla; Umar, Yunusa; Ashwaq, Omar; Haque, Sk Manirul

doi:10.4067/s0717-97072020000204895

Cited by 14 publications

(4 citation statements)

References 32 publications

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“…The validation of the analysis method was based on the method from Judeh et al [51] and Naz et al [52], with minor modifications in weight and concentration. Validation includes accuracy, precision, detection limit, quantitation limit, linearity, and range.…”

Section: Validation Of the Infrared Spectrophotometry Methodsmentioning

confidence: 99%

Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets

et al. 2021

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(1) Background: The functional groups present in tranexamic acid allow direct infrared detection analysis. This study aimed to develop, apply, and validate an infrared spectrophotometry method used for qualitative and quantitative analyses of tranexamic acid in marketed tablets. (2) Methods: This was a descriptive observational study that consisted of several stages: determining the specific wavenumber for analysis, obtaining a simple linear regression equation, analyzing tranexamic acid both qualitatively and quantitatively, and validating the developed method for routine analysis. (3) Results: The peak analysis obtained a range of baseline wavenumbers from 1679.17 to 1295.25 cm−1. The regression equation obtained was Y = 310.8527 × X + 0.9718, and the coefficient of determination (R2) obtained was 0.9994. The tranexamic acids in marketed tablets overall have a similarity index value of more than 0.90 and overall have levels ranging between 97.0% and 103.0%. The infrared spectrophotometry method that was successfully developed, applied, and validated for qualitative and quantitative analyses of tranexamic acid in marketed tablets meets the requirements both qualitatively and quantitatively of the tablet monograph. (4) Conclusions: The infrared spectrophotometry method has been validated and meets the requirements for accuracy, precision, detection limit, quantitation limit, linearity, range, and specificity.

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Section: Validation Of the Infrared Spectrophotometry Methodsmentioning

confidence: 99%

Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets

et al. 2021

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“…The mobile phase was a combination of solvents (water: methanol: glacial acetic acid=4:6:0.5 v/v/v) having different polarities to elute the compound. When it reached optimum length, the resulting separation of compounds was removed and dried in an oven and collected the pure atorvastatin as solid 47 .…”

Section: Extraction Of Atorvastatin From Pharmaceuticalsmentioning

confidence: 99%

Development and Validation of HPLC Method for the Quantification of Atorvastatin in Pharmaceutical Dosage Forms and Biological Fluid

Haque

2021

Mediterr.J.Chem.,

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A reverse phase HPLC method was developed for the determination of atorvastatin. The mobile phase involved for the separation was phosphate buffer and acetonitrile with a ratio of 10:1. The HPLC column C18 ODS hypersil column (250 mm×4.6 mm, 5 μm) was used and detected at 215 nm. The run time of the current method was 5 minutes with excellent specificity; no interferences were observed in the pharmaceutical dosage form. The process was validated according to ICH guidelines. The linearity of the proposed method was within the range of 0.25–3.8 µg/ml. The LOD and LOQ values were found to be 0.21 and 0.64 µg/ml. The % recovery and %RSD were within the range of 98–100 %, and ±2% for accuracy, precision, robustness, ruggedness results. All the values are acceptable as per ICH guidelines. As well, this enhanced technique was applied to calculate the amount of atorvastatin in human urine samples. Therefore, the present method is reliable for quantifying atorvastatin in quality control samples in academic and pharmaceutical industries and can easily be used in research development and hospitals.

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“…METquality control (QC) generally requires an assay with a high throughput capability. For the purpose of determining MET, several instrumental techniques have been developed [13]. Tese techniques include high-performance liquid chromatography [14,15], UV-visible spectrophotometry [16][17][18], LC-MS/MS [19,20], electrochemical methods of analysis [21][22][23][24][25], spectrofuorimetric methods [26], and varied HPTLC techniques [27][28][29].…”

Section: Introductionmentioning

confidence: 99%

Validation and Application of Screen-Printed Microchip for Potentiometric Determination of Metformin Hydrochloride in Tablet Dosage Form

Alqarni,

Alshehri,

Arida

2024

International Journal of Analytical Chemistry

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Metformin is an oral biguanides hypoglycaemic agent, which used to lower the blood glucose levels in people with type 2 diabetes mellitus. Many analytical techniques have been used to quantify the drug in different pharmaceutical dosage forms; however, most of these methods have limited throughput in the quality control application. A disposable potentiometric microsensor responsive to metformin has recently been reported. For the first time, herein, this method of analysis has been validated according to IUPAC recommendations and successfully applied in the determination of metformin drug in some dosage form. Different drug formulations of metformin hydrochloride have been collected from the local pharmaceutical stores in Saudi Arabia and analysed using the validated microchip-based method of analysis. Subsequently, the results of this study showed that the validated method was linear, specific, precise, and accurate. The linear range was 1 × 10−1–1 × 10−5 mol L−1 and the correlation coefficient was 0.999. The limit of detection was 2.89 × 10−6 mol L−1, and the limit of quantification was 8.77 × 10−6 mol L−1. This method demonstrated high precision, with an RSD% of less than 2.22%. The accuracy of this method was obtained by comparing the recovery percentage with percentage values less than 5%. The results obtained showed that there was no significant difference between the references, label, and recovery of less than 5%.

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Development, Computational Studies and Validation of Spectrophotometric Method of Metformin Hydrochloride in Pharmaceutical Formulations

Cited by 14 publications

References 32 publications

Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets

Validation of the Developed Zero-Order Infrared Spectrophotometry Method for Qualitative and Quantitative Analyses of Tranexamic Acid in Marketed Tablets

Development and Validation of HPLC Method for the Quantification of Atorvastatin in Pharmaceutical Dosage Forms and Biological Fluid

Validation and Application of Screen-Printed Microchip for Potentiometric Determination of Metformin Hydrochloride in Tablet Dosage Form

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