Browsing by Author "Lotfy, Hayam M"

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Advanced Approaches in Green Univariate Spectrophotometric Methods
(wiley, 2024-01) Lotfy, Hayam M; Saleh, Sarah S; Rostom, Yasmin; Obaydo, Reem H; Ahmed, Dina A
The pharmaceutical industry and market have shown a tremendous evolution where different new pharmaceuticals and pharmaceutical combinations have been introduced in order to increase patient compliance and obtain the required outcomes. On the other hand, this evolution has raised a challenge in the field of drug analysis, where new applicable methods of analysis needed to be developed and validated to ensure that the right doses would reach patients free from any undesired compounds such as impurities, adulterants, or interfering substances that might lead to any undesirable side effects. This chapter highlights the advanced approaches in green univariate spectrophotometric methods based on basic mathematical techniques, such as subtraction, division, and multiplication, for assaying the components of multicomponent mixtures in their different pharmaceutical dosage forms utilising inexpensive, affordable, and eco-friendly facilities.
A Comparative Study of Spectrophotometric Methods Versus Chemometric Methods; An Application on a Pharmaceutical Binary Mixture of Ofloxacin and Dexamethasone
(3/17/2013) Saleh, Sarah S; Lotfy, Hayam M; Elgizawy, Samia M; Hassan, Nagiba Y
Aim: To conduct a comparative study between the smart novel ratio difference spectrophotometric method (RDSM) versus four spectrophotometric methods: first derivative spectrophotometry (D1), first derivative of the ratio spectra (1DD), isoabsorpative point (Aiso), ratio subtraction (RS), and two chemometric techniques based on principal component regression (PCR) and partial least-squares (PLS-1) for the determination of a binary mixture of Ofloxacin (OFX) and Dexamethasone (DXM). Study Design: The results obtained from the proposed methods were statistically compared to the reported HPLC method using student’s t-test, F-test and One way ANOVA. Methodology: (OFX) was determined by the application of direct spectrophotometry, by measuring its zero-order (D0) absorption spectra at its λmax = 296.6 nm. (DXM) was determined by (D1) at 227.1 nm. By applying (1DD), (DXM) was determined at 237.3. The total concentration of both (OFX + DXM) was determined at their isoabsorpative point λiso= 238.3 nm, then the concentration of (DXM) in mixtures were calculated by subtraction. (DXM) was determined using the (RS) method at its λmax = 239 nm. (DXM) was determined using (RDSM) by measuring amplitude difference at two selected wavelengths (248.4 and 290 nm). A concentration of 10 µg.mL-1 of OFX was used as a divisor. The linearity range was found to be (1-10 µg.mL-1) and (2-14 µg.mL-1) for OFX and DXM respectively. Results: The recovery percentage for OFX was found to be 100.07 ±0.65 and for DXM was found to be 100.41 ±0.84, 100.15 ±0.97, 100.14 ±0.91, 100.54 ±0.75 and 100.11 ±.66 for the five methods, respectively. Conclusion: The novel method showed advantages over the other proposed methods regarding simplicity, minimal data manipulation and maximum reproducibility and robustness; which enabled the analysis of binary mixtures with overlapped spectra for routine quality control testing with quite satisfactory and in lower cost.
A Comparative Study of the Novel Ratio Difference Method versus Conventional Spectrophotometric Techniques for the Analysis of Binary Mixture with Overlapped Spectra
(Scientific Research Publishing, 2012) Elgizawy, Samia M.; Hassan, Nagiba Y; Saleh, Sarah S; Lotfy, Hayam M
The smart novel ratio difference spectrophotometric method was developed and validated for the determination of a binary mixture of Sodium cromoglicate (SCG) and Fluorometholone (FLU) in presence of benzalkonium chloride without prior separation. The results were compared to that of the conventional methods (dual wavelength and first derivative of ratio spectra). The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for determination of SCG and FLU in their laboratory prepared mixtures and commercial ophthalmic solution. The novel method showed significant advantages over the conventional methods regarding simplicity, minimal data manipulation and maximum reproducibility and robustness; which enabled the analysis of binary mixtures with overlapped spectra for routine quality control testing with quite satisfactory.
Guidelines for Accurate Application of Green and White Analytical Concepts: Merits Vs Demerits with Insights of Significant Milestones of Assessment Tools Applied for Antiviral Drugs
(Elsevier Inc, 2024-01) Saleh, Sarah S; Obaydo, Reem H; El Hamd, Mohamed A; Rostom, Yasmin; Mohamed, Dalia; Lotfy, Hayam M
In recent years, there has been a growing focus in analytical research on the ecological and sustainable aspects of analytical methodologies. However, it is necessary to apply the relevant metrics to evaluate the effectiveness of certain analytical methods. The present study aims to conduct a thorough analysis of the major turning points, merits, and demerits of some reported methods carried out to determine anti-viral drugs. Since the COVID-19 pandemic in 2020, researchers have become interested in antiviral drugs because it was the class of interest for facing the challenges of this pandemic. That’s why, a comprehensive application of several relevant green metrics has been reviewed. Additionally, the study intends to choose tools that have been reported as being green to use, explain the data that has been gathered, compare the data to one another, and highlight the benefits of particular features in each tool based on the timeline progress of using these tools. In addition, suggestions were made for adapting each tool to the recommended guidelines. Case studies were presented to highlight the proper application of each assessment tool.
Guidelines for accurate application of green and white analytical concepts: Merits Versus demerits with insights of significant milestones of assessment tools applied for antiviral drugs
(Elsevier Inc, 2024-01) Saleh, Sarah S; Obaydo, Reem H; El Hamd, Mohamed A; Rostom, Yasmin; Mohamed, Dalia; Lotfy, Hayam M
In recent years, there has been a growing focus in analytical research on the ecological and sustainable aspects of analytical methodologies. However, it is necessary to apply the relevant metrics to evaluate the effectiveness of certain analytical methods. The present study aims to conduct a thorough analysis of the major turning points, merits, and demerits of some reported methods carried out to determine anti-viral drugs. Since the COVID-19 pandemic in 2020, researchers have become interested in antiviral drugs because it was the class of interest for facing the challenges of this pandemic. That’s why, a comprehensive application of several relevant green metrics has been reviewed. Additionally, the study intends to choose tools that have been reported as being green to use, explain the data that has been gathered, compare the data to one another, and highlight the benefits of particular features in each tool based on the timeline progress of using these tools. In addition, suggestions were made for adapting each tool to the recommended guidelines. Case studies were presented to highlight the proper application of each assessment tool.
A high-throughput UPLC-MS-MS Bio-analytical method for the analysis of veterinary pharmaceutical residues in Chicken Tissues, Application of efficient-valid-green (EVG) Framework as a Competence Tool
(Elsevier B.V, 2024-04) Saleh, Sarah S; Samir, Ahmed; Lotfy, Hayam M; Nessim, Christine K
Antibacterial medications are receiving the most attention due to hypersensitivity reactions and the emergence of bacterial mutants resistant to antibiotics. Treating Animals with uncontrolled amounts of antibiotics will extend beyond their lives and affect humans. This study aims to determine the concentration of the residues of sulfadimidine, sulfaquinoxaline, diaveridine, and vitamin K3 in the tissues of poultry (muscles and liver) after treatment with the combined veterinary formulation. A UPLC-MS-MS method was developed using Poroshell 120 EC[sbnd]C18 and a mobile phase composed of acetonitrile and distilled water, containing 0.1 % formic acid, in the ratio of (85:15 v/v) at a flow rate of 0.6 mL/min. Sample extraction solvent was optimized using response surface methodology (RSM) to be acetonitrile: methanol in the ratio (49.8: 50.2 v/v), and the method was validated according to the FDA bioanalytical method validation protocol over the range (50–1000 µg/Kg) for sulfaquinoxaline and (50–750 µg/Kg) for the other 3 drugs. The greenness of the sample preparation and analytical method was assessed by applying Analytical Eco-scale (AES) and AGREE coupled with AGREEprep. The Competence of the study was evaluated via the EVG framework known as Efficiency, validation, and greenness, to achieve a balance point represented by a radar chart. The method was applied to decide the time required for poultry products to be safe for human use after administration of the studied drugs. It was found that, after the administration of the last dose, minimally 7 days are required till the levels of the drugs drop to the maximum residue limit determined by the FDA/WHO in animal tissues.
The power of High Impact Amplitude Manipulation (HIAM) technique for extracting the basic spectra of two Fixed-dose combinations (FDC) -Spectrophotometric purity analysis via spectral contrast angle
(Elsevier, 15/02/2022) Saleh, Sarah S; Lotfy, Hayam M; Tiris, Gizem; Erk, Nevin; El-Naem, Omnia A
HIAM technique allows the extraction of the original constant signal of each single component out of interference signals of a mixture and further transformed into basic spectrum (D0 ). It includes the meth- ods: ratio subtraction coupled with unified constant subtraction (RS-UCS), constant center (CC) and con- stant extraction (CE). The technique was introduced for the analysis of two pharmaceutical formulations used to treat cardiovascular diseases. The formulations are binary combinations of Amlodipine (AML) with either Atorvastatin (ATR) or Candesartan (CND) which shows interefernce absorbance signals. The technique was valid over the linearity range of (5.0–35.0 mg/ml) for AML, ATR and CND with recovery per- centage 100.40 ± 1.88 , 100.00 ± 0.86 and 99.83 ± 1.07, respectively . The extracted signals were tested for its purity by spectral contrast angle (cos h) to illustrate the efficency of the HIAM technique where cos h values ranges from (0.9902 to 0.9986). The presented technique was fully validated regarding ICH guide- lines and were statistically compared using one-way ANOVA at 95% confidence.
Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy Volume 273, 15 May 2022, 121036 The power of High Impact Amplitude Manipulation (HIAM) technique for extracting the basic spectra of two Fixed-dose combinations (FDC) -Spectrophotometric purity analysis via spectral contrast angle
(Elsevier, 01/05/2022) Saleh, Sarah S; Lotfy, Hayam M; Tiris, Gizem; Erk, Nevin; El-Naem, Omnia A
HIAM technique allows the extraction of the original constant signal of each single component out of interference signals of a mixture and further transformed into basic spectrum (D0). It includes the methods: ratio subtraction coupled with unified constant subtraction (RS-UCS), constant center (CC) and constant extraction (CE). The technique was introduced for the analysis of two pharmaceutical formulations used to treat cardiovascular diseases. The formulations are binary combinations of Amlodipine (AML) with either Atorvastatin (ATR) or Candesartan (CND) which shows interefernce absorbance signals. The technique was valid over the linearity range of (5.0–35.0 µg/ml) for AML, ATR and CND with recovery percentage 100.40 ± 1.88 , 100.00 ± 0.86 and 99.83 ± 1.07, respectively . The extracted signals were tested for its purity by spectral contrast angle (cos θ) to illustrate the efficency of the HIAM technique where cos θ values ranges from (0.9902 to 0.9986). The presented technique was fully validated regarding ICH guidelines and were statistically compared using one-way ANOVA at 95% confidence
Univariate versus Multivariate Spectrophotometric Methods for Simultaneous Determination of Complex Binary Mixtures with Overlapped Spectra: A Comparative Study
(Taylor & Francis, 2013-09) Elgizawy, Samia M.; Hassan, Nagiba Y; Saleh, Sarah S.; Lotfy, Hayam M
Two novel simple and accurate univariate spectrophotometric methods were described for the determination of a binary mixture of Sodium cromoglicate (SCG) and Fluorometholone (FLU) namely; ratio subtraction coupled with extended ratio subtraction (RS-EXRSM) and constant center (CCSM) spectrophotometric methods. The methods were able to recover the zero order absorption spectra of both drugs from their binary mixture through simple mathematical calculations. The linearity ranges were found to be (2.5–25 µg/mL) and (4- 25 µg/mL) for SCG and FLU, respectively. A comparative study was conducted between the proposed univariate methods versus multivariate ones, based on using principle component regression (PCR) and partial least squares (PLS-2). Upon applying the methods for the determination of SCG and FLU in laboratory prepared mixtures, the (CCSM and PLS-2) proved to be of higher predictive ability rather than (RS-EXRSM and PCR) in prediction of mixtures containing low concentration of one of the components. The proposed methods were validated in compliance with the ICH guidelines. These methods could be alternative to different HPLC techniques in quality control laboratories lacking the required facilities for those expensive techniques