Heba M. Mohamed

Rapid and Highly Sensitive HPLC and TLC Methods for Quantitation of Amlodipine Besilate and Valsartan in Bulk Powder and in Pharmaceutical Dosage Forms and in Human Plasma

Two simple, sensitive, and specific high-performance liquid chromatography and thin-layer chromatography methods were developed for the simultaneous estimation of Amlodipine besilate (AM) and Valsartan (VL). Separation by HPLC was achieved using a xTerra C18 column and methanol /acetonitrile /water/ 0.05% triethylamine in a ratio 40:20:30:10 by volume as mobile phase, pH was adjusted to 3 ± 0.1 with o-phosphoric acid. The flow rate was 1.2 mL min−1. The linearity range was 0.2 to 2 µg mL−1 for amlodipine besilate and 0.4 to 4 µg mL−1 for Valsartan with a mean percentage recovery of 99.59 ± 0.523% and 100.61 ± 0.400% for amlodipine besilate and valsartan, respectively. The TLC method used silica gel 60 F254 plates; the optimized mobile phase was ethyl acetate/ methanol / ammonium hydroxide (55:45:5 by volume). Quantitatively, the spots were scanned densitometrically at 237 nm. The range was 0.5–4.0 µg spot−1 for amlodipine besilate and 2.0–12.0 µg spot−1 for valsartan. The mean percentages recovery was 99.80 ± 0.451% and 100.61 ± 0.363% for amlodipine besilate and valsartan, respectively. The HPLC method was found to be simple, selective, precise, and reproducible for the estimation of both drugs from spiked human plasma.

Educational Games as a Teaching Tool in Pharmacy Curriculum

The shift in the pharmacist’s role from simply dispensing medications to effective delivery of pharmaceutical care interventions and drug therapy management has influenced pharmacy education.1-3 The educational focus has shifted from basic sciences to clinical and integrated courses that require incorporating active-learning strategies to provide pharmacy graduates with higher levels of competencies and specialized skills. As opposed to passive didactic lectures, active-learning strategies address the educational content in an interactive learning environment to develop interpersonal, communication, and problem-solving skills needed by pharmacists to function effectively in their new roles.4-6 One such strategy is using educational games. The aim of this paper is to review educational games adopted in different pharmacy schools and to aid educators in replicating the successfully implemented games and overcoming deficiencies in educational games. This review also highlights the main pitfalls within this research area.

A study of selective spectrophotometric methods for simultaneous determination of Itopride hydrochloride and Rabeprazole sodium binary mixture: Resolving sever overlapping spectra.

Itopride hydrochloride (IT) and Rabeprazole sodium (RB) are co-formulated together for the treatment of gastro-esophageal reflux disease. Three simple, specific and accurate spectrophotometric methods were applied and validated for simultaneous determination of Itopride hydrochloride (IT) and Rabeprazole sodium (RB) namely; constant center (CC), ratio difference (RD) and mean centering of ratio spectra (MCR) spectrophotometric methods. Linear correlations were obtained in range of 10-110μg/μL for Itopride hydrochloride and 4-44μg/mL for Rabeprazole sodium. No preliminary separation steps were required prior the analysis of the two drugs using the proposed methods. Specificity was investigated by analyzing the synthetic mixtures containing the two cited drugs and their capsules dosage form. The obtained results were statistically compared with those obtained by the reported method, no significant difference was obtained with respect to accuracy and precision. The three methods were validated in accordance with ICH guidelines and can be used for quality control laboratories for IT and RB.

Analytical Eco-Scale for Assessing the Greenness of a Developed RP-HPLC Method Used for Simultaneous Analysis of Combined Antihypertensive Medications.

In the past few decades the analytical community has been focused on eliminating or reducing the usage of hazardous chemicals and solvents, in different analytical methodologies, that have been ascertained to be extremely dangerous to human health and environment. In this context, environmentally friendly, green, or clean practices have been implemented in different research areas. This study presents a greener alternative of conventional RP-HPLC methods for the simultaneous determination and quantitative analysis of a pharmaceutical ternary mixture composed of telmisartan, hydrochlorothiazide, and amlodipine besylate, using an ecofriendly mobile phase and short run time with the least amount of waste production. This solvent-replacement approach was feasible without compromising method performance criteria, such as separation efficiency, peak symmetry, and chromatographic retention. The greenness profile of the proposed method was assessed and compared with reported conventional methods using the analytical Eco-Scale as an assessment tool. The proposed method was found to be greener in terms of usage of hazardous chemicals and solvents, energy consumption, and production of waste. The proposed method can be safely used for the routine analysis of the studied pharmaceutical ternary mixture with a minimal detrimental impact on human health and the environment.

Application and validation of an eco-friendly TLC-densitometric method for simultaneous determination of co-formulated antihypertensive agents

Owing to the greater awareness that has arisen within the analytical community regarding the colossal negative influence of hazardous chemicals on both health and the environment, there is an increasing interest in developing more environment-friendly practices in different research areas. In this context, an eco-friendly TLC-densitometric method was designed, optimized and validated for the quantitative analysis of a ternary pharmaceutical mixture used for hypertension management, in the pure powdered form, synthetic mixtures and combined pharmaceutical formulation. The proposed method is based on the separation of the three co-formulated drugs; telmisartan (TL), hydrochlorothiazide (HZ) and amlodipine besylate (AM) on silica gel F254 plates, using green solvents as the developing system. The method was validated with regard to linearity, accuracy, precision, system suitability, and robustness. Comparison of the suggested method to the reported conventional TLC-densitometric method, regarding their validation parameters and greenness profiles, was carried out. The suggested method was found to be more eco-friendly and more solvent-/time-saving; hence it can be used for quality control analysis of the studied mixture in a safer way.

Application and validation of superior spectrophotometric methods for simultaneous determination of ternary mixture used for hypertension management

Telmisartan (TL), Hydrochlorothiazide (HZ) and Amlodipine besylate (AM) are co-formulated together for hypertension management. Three smart, specific and precise spectrophotometric methods were applied and validated for simultaneous determination of the three cited drugs. Method A is the ratio isoabsorptive point and ratio difference in subtracted spectra (RIDSS) which is based on dividing the ternary mixture of the studied drugs by the spectrum of AM to get the division spectrum, from which concentration of AM can be obtained by measuring the amplitude values in the plateau region at 360nm. Then the amplitude value of the plateau region was subtracted from the division spectrum and HZ concentration was obtained by measuring the difference in amplitude values at 278.5 and 306nm (corresponding to zero difference of TL) while the total concentration of HZ and TL in the mixture was measured at their isoabsorptive point in the division spectrum at 278.5nm (Aiso). TL concentration is then obtained by subtraction. Method B; double divisor ratio spectra derivative spectrophotometry (RS-DS) and method C; mean centering of ratio spectra (MCR) spectrophotometric methods. The proposed methods did not require any initial separation steps prior the analysis of the three drugs. A comparative study was done between the three methods regarding their; simplicity, sensitivity and limitations. Specificity was investigated by analyzing the synthetic mixtures containing different ratios of the three studied drugs and their tablets dosage form. Statistical comparison of the obtained results with those found by the official methods was done, differences were non-significant in regard to accuracy and precision. The three methods were validated in accordance with ICH guidelines and can be used for quality control laboratories for TL, HZ and AM.

Chromatographic methods for the simultaneous determination of metoprolol tartrate and hydrochlorothiazide in the presence of hydrochlorothiazide degradation product

Metoprolol tartrate (MT) (Figure 1) is a selective adrenergic antagonist that is devoid of intrinsic sympathomimetic activity [1]. It is used in the management of hypertension, angina pectoris, cardiac arrhythmia, and myocardial infarction [2]. Hydrochlorothiazide (HZ) (Figure 1) is a thiazide diuretic that is used in the treatment of hypertension, either alone or with other antihypertensives. It is also used to treat edema associated with heart failure, with renal and hepatic disorders, and with acute glomerulonephritis [1, 2]. MT and HZ are co-formulated together in commercial tablets for their antihypertensive effect.