, K. Dianpratami , M. Wulandari , R. Rahmawati , Validation of metforminhydrochloride in human plasma by HPLC-photo diode array (PDA) for application of bioequivalence study , J. Life Sci. 6 ( 2012
Authors:Jules Muhire, Bao Qiong Li, Hong Lin Zhai, Xue Wang, and Min Li Xu
diabetes globally [ 1 ]. Metforminhydrochloride (MFH), a developed drug from a herb, Galega officinalis , has been used as the foremost line therapy in the treatment of type 2 diabetes mellitus patients [ 2 ]. Chemically, it is N , N
A simple, rapid, and precise reversed-phase high-performance liquid chromatographic method for simultaneous analysis of metformin hydrochloride, pioglitazone hydrochloride, and glibenclamide in a tablet dosage form has been developed and validated. Chromatography was performed on a 25 cm × 4.6 mm i.d., 5-μm particle, C18 column with 55:45 (v/v) acetonitrile — potassium dihydrogen phosphate buffer (pH adjusted to 3.0 ± 0.1 with 5% orthophosphoric acid) as mobile phase at a flow rate of 1.5 mL min−1. UV detection was performed at 230 nm. Total run time was 10 min; metformin hydrochloride, pioglitazone hydrochloride, and glibenclamide were eluted with retention times of 1.362, 3.418, and 7.395 min, respectively. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the concentration ranges 200–1000 μg mL−1 for metformin hydrochloride, 200–1000 μg mL−1 for pioglitazone hydrochloride, and 50–300 μg mL−1 for glibenclamide. Limits of detection were 6.3, 15.4, and 8.2 ng mL−1 and limits of quantification were 19.09, 46.66, and 24.84 ng mL−1 for metformin hydrochloride, pioglitazone hydrochloride, and glibenclamide, respectively. The high recovery and low coefficients of variation confirm the suitability of the method for simultaneous analysis of the three drugs in tablets. The validated method was successfully used for quantitative analysis of triglycomate tablets.
Authors:Sally Nasser, Ismail Salama, Samia M. Mostafa, and Mohamed Saleh Elgawish
The discovery of potent antidiabetic drugs is of necessity owing to the rapid prevalence of diabetes worldwide. The investigation of a new separation method for the simultaneous determination of combined antidiabetic drugs is thus an essential issue to cover the usual demands of simple analytical methods for the routine analysis. Therefore, herein, simple and fast chromatographic methods were established for synchronized determination of metformin (MET) and dapagliflozin (DAP), a mixture approved recently by the Food and Drug Administration (FDA) for diabetes therapy. In high-performance liquid chromatography (HPLC), a Water-pak C18 column was used as the stationary phase with an isocratic mobile phase composed of 10 mM NaH2PO4 (pH 3.5 adjusted using ortho-phosphoric acid)‒acetonitrile (65:35, v/v) containing 0.1% trimethylamine at a flow rate of 1.2 mL min−1 and a wavelength detector set at 225 nm. In high-performance thin-layer chromatography (HPTLC), separation was achieved on pre-coated silica gel 60 F254 aluminum plates using acetonitrile‒ammonium acetate 10%‒acetic acid (9:0.9:0.1, v/v). The proposed methods were validated in the light of the International Conference on Harmonization (ICH) guidelines, and it was found that the two chromatographic methods are accurate, precise, and linear in the range of 2–20 μg mL−1 and 1–10 μg per spot for DAP and 20–400 μg mL−1 and 10–100 μg per spot for MET by HPLC and HPTLC, respectively. The methods achieved a reasonable sensitivity as shown by the low limit of detection ranging from 0.58 to 6.1 μg mL−1 and 0.314 to 3.1 μg per spot for HPLC and HPTLC, respectively. The validated methods succeeded in detecting the cited drugs in pharmaceutical formulation without interference of excipients. Although HPLC method is the most applicable method, HPTLC method exhibits a superior sensitivity and is cheap and fast allowing the determination of a large number of samples in due time.
Authors:Ravi Bhushan, Deepak Gupta, and Aishwarya Jain
A simple and sensitive method for separation and quantitative determination of antidiabetic drugs in pharmaceutical preparations has been established and validated. Commercial formulations of five antidiabetic drugs (metformin, pioglitazone, rosiglitazone, glibenclamide, and gliclazide) were chosen for the studies. The compounds were extracted, isolated, purified, recrystallized, and characterized by measurement of melting point,
, and IR. Quantitative determination was performed by HPLC, TLC, and column chromatography supplemented with UV spectrophotometry. Two of the combinations, metformin + pioglitazone and metformin + gliclazide, were separated by open-column chromatography. Detection was by UV spectrophotometry in HPLC and by use of iodine vapor in TLC.