Development and validation of a reversed phase liquid chromatographic method for the determination of three Gliptins and Metformin in the presence of Metformin impurity (1-cyanoguanidine)

El‐Bagary, Ramzia I.; Elkady, Ehab F.; Ayoub, Bassam M.

doi:10.5155/eurjchem.4.4.444-449.844

Cited by 9 publications

(8 citation statements)

References 15 publications

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“…The proposed method results were satisfactorily compared with those of reported method. 16 The results obtained from the statistical analysis 29 showed no signicant difference between the performances of the proposed and reference methods using student's t-test and variance ratio F-test, (Table 3).…”

Section: Methods Validationmentioning

confidence: 95%

“…Its purity was found to be 99.76% according to a reported method. 16 Vildagliptin was supplied from Novartis Europharm Ltd. Co. (London, U.K.). Its purity was found to be 99.64% according to a reported method.…”

Section: Chemicals and Reagentsmentioning

confidence: 99%

“…Its purity was found to be 99.64% according to a reported method. 16 Metformin hydrochloride was kindly supplied by Chemical Industries Development (CID) Co. (Giza, Egypt). Its purity was found to be 100.04% according to a reported method.…”

Section: Chemicals and Reagentsmentioning

confidence: 99%

“…These methods have included spectrophotometry and spectrouorimetry, 9 HPLC and stability-indicating HPLC methods. [10][11][12][13][14][15][16] Considering the aforementioned stability indicating studies, STG and MET were determined in presence of their degradation products by HPLC-UV in concentration ranges of 10-30 ppm and 100-300 ppm, respectively as performed by Kumar et al 13 R. I. El-Bagary et al, 11 have also utilized HPLC-UV for quantication of STG and MET in presence of STG alkaline degradation product in the range of 5-160 mg mL À1 and 25-800 mg mL À1 , respectively. Simultaneous estimation of STG, MET and their impurities was carried out by a stability indicating method manifesting a good separation using HPLC-UV, where STG and MET were estimated in concentration range of 10-150 mg mL À1 and 50-450 mg mL À1 , respectively.…”

Section: Introductionmentioning

confidence: 99%

“…In addition, several HPLC-UV methods were performed. 16,[21][22][23][24] However, LC methods based on UV and DAD detectors show moderate sensitivity and selectivity for complex matrices such as plasma. Thus all of these methods [21][22][23][24] have revealed microgram linearity ranges for both drugs.…”

Section: Introductionmentioning

confidence: 99%

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Novel contribution to the simultaneous analysis of certain hypoglycemic drugs in the presence of their impurities and degradation products utilizing UPLC-MS/MS

Mowaka

Mohamed

2015

RSC Adv.

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A novel ultra-performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS) method was established for simultaneous determination of three hypoglycemic drugs namely; sitagliptin (STG), vildagliptin (VLG) and metformin (MET) in the presence of their degradation products and STG related impurities. Chromatographic separation was accomplished on a Hypersil gold 50 mm Â 2.1 mm (1.9 mm) column, using acetonitrile and 0.2% formic acid aqueous solution as the mobile phase with a gradient elution. Electrospray ionization (ESI) source was operated in the positive ion mode. The selected reaction monitoring (SRM) mode on a triple quadrupole mass spectrometer was used to quantify the drugs utilizing the transitions of 408.12 / 235.24 (m/z), 304.33 / 154.32 (m/z), 130.12 / 71.32 (m/z) and 255.75 / 166.15 (m/z), for STG, VLG, MET and diphenhydramine (IS), respectively. The method has displayed a lower limit of detection of 1.50 ng mL À1 , 1.50 ng mL À1 and 3.00 ng mL À1 for STG, VLG and MET, respectively. The drugs were subjected to forced degradation where it was concluded that STG, VLG and MET were highly susceptible for alkaline stress conditions. In addition, the study of the degradation kinetics of the drugs has proved that the degradation follows a pseudo-first-order reaction.The proposed method was effectively applied for the analysis of laboratory prepared mixtures as well as combined pharmaceutical formulations. No significant difference was found regarding accuracy and precision upon statistical comparison of the obtained results with those of the reported method.Validation was conducted in compliance with the ICH guidelines proving the method to be selective, linear, precise and accurate. The simplicity and sensitivity of this method allows its use in the quality control of the cited drugs. Scheme 1 The proposed structures and pathways of the main degradation products of STG produced under (a) alkaline degradation and (b) acid degradation. 60476 | RSC Adv., 2015, 5, 60467-60481 This journal is

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Section: Methods Validationmentioning

confidence: 95%

Section: Chemicals and Reagentsmentioning

confidence: 99%

Section: Chemicals and Reagentsmentioning

confidence: 99%