Browsing by Author "El Bayoumi Abdel Aleem, Abdel-Aziz"

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Simultaneous determination of pioglitazone and glimepiride in their pharmaceutical formulations
(Scholars Research Library, Der Pharma Chemica, 2011) R. Rezk, Mamdouh; M. Riad, Safa'a; Y. Mahmoud, Ghada; El Bayoumi Abdel Aleem, Abdel-Aziz
Two sensitive and precise methods were developed and validated for the simultaneous determination of pioglitazone hydrochloride and glimepiride as the bulk drugs and in their pharmaceutical formulations. Among the techniques adopted were chromatography [coupled TLC-densitometry and HPLC].Method I : Densitometric separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of chloroform: toluene: glacial acetic acid: ethanol [4.5:4.5:1:1, v/v/v/v]. Densitometric evaluation of the separated zones was performed at 228 nm and 268 nm. The two drugs were satisfactorily resolved with RF values 0.4and 0.65 for pioglitazone hydrochloride and glimepiride, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity 3-15µg/spot for pioglitazone hydrochloride and 0.1-3 µg/spot for glimepiride, precision (intra-day RSD 1.178% and inter-day RSD 1.152 % for pioglitazone hydrochloride, and intra-day RSD 1.101 % and inter-day RSD 0.999 % for glimepiride), accuracy (99.94 ± 1.30 % for pioglitazone hydrochloride and 100.74 ±1.58 % for glimepiride) and specificity, in accordance with ICH guidelines. Method II: chromatographic separation using a 250 mm x 4.6 mm, i.d. C18Lichrosorb™ 10µm analytical column. The mobile phase consisted of phosphate buffer [pH: 4]: methanol: acetonitrile: triethylamine [40:20:40:0.1, v/v/v/v] The average retention times under the conditions described were 4 minutes for pioglitazone hydrochloride and 7.5 minutes for Glimepiride, accuracy and reliability of the method was assessed by evaluation of linearity 5-175 µg/mL for pioglitazone hydrochloride and 5-30µg/mL for Glimepiride, precision (intra-day RSD 0.295% and inter-day RSD 0.215 % for pioglitazone hydrochloride, and intra-day RSD 0.345 % and inter-day RSD 0.231 % for glimepiride), accuracy (99.80 ± 1.16 % for pioglitazone hydrochloride and 99.47 ±2.07 % for glimepiride) and specificity, in accordance with ICH guidelines.
Spectrophotometric determination of sitagliptin and metformin in their pharmaceutical formulation
(Pharmacie Globale, 2012) M. Riad, Safaa; R. Rezk, Mamdouh; Y. Mahmoud, Ghada; El Bayoumi Abdel Aleem, Abdel-Aziz
Two simple, accurate and precise spectrophotometric methods were developed and validated for the determination of sitagliptin phosphate monohydrate (STA) and metformin hydrochloride (MTF). The first method was based on measuring the absorbance of STA at 268 nm in the range of 25-500 µg mL-1. The second method was the isosbestic point method. The total mixture concentration was calculated by measuring the absorbance at 257 nm. The proposed methods used to determine each drug in binary mixture. The results were statistically compared using one-way analysis of variance (ANOVA). The developed methods were satisfactory applied to the analysis of the pharmaceutical formulation and proved to be selective and accurate for the quality control of the cited drugs in their pharmaceutical formulation.