scholarly journals Study of component distribution in pharmaceutical binary powder mixtures by near infrared chemical imaging

2012 ◽  
Author(s):  
Manel Bautista ◽  
Jordi Cruz ◽  
Marcelo Blanco
Keyword(s):  
Least Squares ◽  
Visual Information ◽  
Near Infrared ◽  
Spatial Information ◽  
Imaging Techniques ◽  
Rapid Assessment ◽  
Chemical Imaging ◽  
Pharmaceutical Products ◽  
Multivariate Curve Resolution ◽  
Component Distribution

Near infrared chemical imaging (NIR-CI) has recently emerged as an effective technique for extracting spatial information from pharmaceutical products in an expeditious, non-destructive and non-invasive manner. These features have turned it into a useful tool for controlling various steps in drug production processes. Imaging techniques provide a vast amount of both spatial and spectral information that can be acquired in a very short time. Such a huge amount of data requires the use of efficient and fast methods to extract the relevant information. Chemometric methods have proved especially useful for this purpose. In this study, we assessed the usefulness of the correlation coefficient (CC) between the spectra of samples, the pure spectra of the active pharmaceutical ingredient (API) and we assessed the excipients to check for correct ingredient distribution in pharmaceutical binary preparations blended in the laboratory. Visual information about pharmaceutical component distribution can be obtained by using the CC. The performance of this model construction methodology for binary samples was compared with other various common multivariate methods including partial least squares, multivariate curve resolution and classical least squares. Based on the results, correlation coefficients are a powerful tool for the rapid assessment of correct component distribution and for quantitative analysis of pharmaceutical binary formulations. For samples of three or more components it has been shown that if the objective is only to determine uniformity of blending, then the CC image map is very good for this, and easy and fast to compute.

Optimisation of Magnification Levels for near Infrared Chemical Imaging of Blending of Pharmaceutical Powders

2007 ◽  
Vol 15 (3) ◽  
pp. 137-151 ◽  
Author(s):  
Hua Ma ◽  
Carl A. Anderson
Keyword(s):  
Near Infrared ◽  
Image Data ◽  
Principal Component ◽  
Chemical Imaging ◽  
Field Of View ◽  
Pharmaceutical Dosage Forms ◽  
Component Distribution ◽  
Circular Field ◽  
Pharmaceutical Powder ◽  
Magnification Level

A critical parameter in the evaluation of pharmaceutical dosage forms by hyperspectral imaging is the level of magnification. If the magnification (as set by the optical objective) is inadequate to resolve the relevant features, then the value of the imaging is diminished; if the magnification level is greater than is required, then the field of view is unnecessarily reduced. The purpose of this study was to determine an optimum magnification level for the study of powder mixing. Relevant features in this system include distribution of individual components within samples and the overall content of a given sample. In the present study, three magnification levels of near infrared (NIR) chemical imaging objectives were evaluated for their effects on imaging a blend of pharmaceutical materials (powders). High, medium and low objective magnification levels were investigated by comparing the resulting blend surface images of a two-component (salicylic acid and lactose) pharmaceutical powder mixture. Multiple images from high and medium magnification were concatenated so that an equivalent field of view was obtained for all magnification levels. Univariate images, principal component analysis score images, partial least squares predicted images and spectra extracted from different intensity regions in the area images were analysed qualitatively and quantitatively for comparison. A series of images spanning a strip across the centre of the circular field were collected at each magnification level and compared with respect to surface features elucidated and area of blend surface imaged. Analyses of images indicate that the three magnification levels delineate the component distribution for this particular powder system similarly. Images obtained at the low magnification level demonstrated adequate resolution and provided the broadest view of the blend surface. It is concluded that the low optical magnification level was adequate for the system being studied and is the preferred mode for pharmaceutical powder blend image data collection for this system.

scholarly journals Simultaneous Determination of Over-the-Counter Pain Relievers in Commercial Pharmaceutical Products Utilizing Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS) Multivariate Calibration Model

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Heba Shaaban ◽  
Ahmed Mostafa ◽  
Zahra Almatar ◽  
Reem Alsheef ◽  
Safia Alrubh
Keyword(s):  
Least Squares ◽  
Multivariate Calibration ◽  
Pharmaceutical Products ◽  
Alternating Least Squares ◽  
Multivariate Curve Resolution ◽  
Calibration Model ◽  
Over The Counter ◽  
Curve Resolution ◽  
Relative Standard ◽  
Significant Difference

The quality of over-the-counter (OTC) pain relievers is important to ensure the safety of the marketed products in order to maintain the overall health care of patients. In this study, the multivariate curve resolution-alternating least squares (MCR-ALS) chemometric method was developed and validated for the resolution and quantification of the most commonly consumed OTC pain relievers (acetaminophen, acetylsalicylic acid, ibuprofen, naproxen, and caffeine) in commercial drug formulations. The analytical performance of the developed chemometric methods such as root mean square error of prediction, bias, standard error of prediction, relative error of prediction, and coefficients of determination was calculated for the developed model. The obtained results are linear with concentration in the range of 0.5–7 μg/mL for acetaminophen and 0.5–3.5 and 0.5–3 μg/mL for naproxen and caffeine, respectively, while the linearity ranges for acetyl salicylic acid and ibuprofen were 1–15 μg/mL. High values of coefficients of determination ≥0.9995 reflected high predictive ability of the developed model. Good recoveries ranging from 98.0% to 99.7% were obtained for all analytes with relative standard deviations (RSDs) not higher than 1.62%. The optimized method was successfully applied for the analysis of the studied drugs either in their single or coformulated pharmaceutical products without any separation step. The optimized method was also compared with a reported HPLC method using paired t-test and F-ratio at 95% confidence level, and the results showed no significant difference regarding accuracy and precision. The developed method is eco-friendly, simple, fast, and amenable for routine analysis. It could be used as a cost-effective alternative to chromatographic techniques for the analysis of the studied drugs in commercial formulations.

scholarly journals Simultaneous Determination of Drugs Affecting Central Nervous System (CNS) in Bulk and Pharmaceutical Formulations Using Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS)

2020 ◽  
Vol 2020 ◽  
pp. 1-8 ◽  
Author(s):  
Heba Shaaban ◽  
Ahmed Mostafa ◽  
Bushra Al-Zahrani ◽  
Bushra Al-Jasser ◽  
Raghad Al-Ghamdi
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Least Squares ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Products ◽  
Alternating Least Squares ◽  
Multivariate Curve Resolution ◽  
Pharmaceutical Dosage Forms ◽  
Curve Resolution ◽  
Significant Difference

The quality of medications is important to maintain the overall health care of patients. This study aims to develop and validate a spectrophotometric method using multivariate curve resolution-alternating least squares (MCR-ALS) with correlation constraint for simultaneous resolution and quantification of selected drugs affecting the central nervous system (imipramine, carbamazepine, chlorpromazine, haloperidol, and phenytoin) in different pharmaceutical dosage forms. Figures of merit such as root-mean-square error of prediction, bias, standard error of prediction, and relative error of prediction for the developed method were calculated. High values of correlation coefficients ranged between 0.9993 and 0.9998 reflected high predictive ability of the developed method. The results are linear in the concentration range of 0.3–5 μg/mL for carbamazepine, 0.3–15 μg/mL for chlorpromazine, 0.5–10 μg/mL for haloperidol, 0.5–10 μg/mL for imipramine, and 3–20 μg/mL for phenytoin. The optimized method was successfully applied for the analysis of the studied drugs in their pharmaceutical products without any separation step. The optimized method was also compared with a reported HPLC method using Student’s t test and F ratio at 95% confidence level, and the results showed no significant difference regarding accuracy and precision. The proposed chemometric method is fast, reliable, and cost-effective and can be used as an eco-friendly alternative to chromatographic techniques for the analysis of the studied drugs in commercial pharmaceutical products.

Reflectance Near-Infrared Spectroscopic Method with a Chemometric Technique Using Partial Least Squares Multivariate Calibration for Simultaneous Determination of Chondroitin, Glucosamine, and Ascorbic Acid

2012 ◽  
Vol 95 (3) ◽  
pp. 724-732 ◽  
Author(s):  
Alaa El-Gindy ◽  
Khalid Abdel-Salam Attia ◽  
Mohammad Wafaa Nassar ◽  
Nasr M A El-Abasawy ◽  
Maisra Al-Shabrawi Shoeib
Keyword(s):  
Ascorbic Acid ◽  
Least Squares ◽  
Simultaneous Determination ◽  
Partial Least Squares ◽  
Near Infrared ◽  
Spectroscopic Method ◽  
Pharmaceutical Products ◽  
Calibration Model ◽  
Drug Concentrations

Abstract A reflectance near-infrared (RNIR) spectroscopy method was developed for simultaneous determination of chondroitin (CH), glucosamine (GO), and ascorbic acid (AS) in capsule powder. A simple preparation of the sample was done by grinding, sieving, and compression of the powder sample for improving RNIR spectra. Partial least squares (PLS-1 and PLS-2) was successfully applied to quantify the three components in the studied mixture using information included in RNIR spectra in the 4240–9780 cm–1 range. The calibration model was developed with the three drug concentrations ranging from 50 to 150% of the labeled amount. The calibration models using pure standards were evaluated by internal validation, cross-validation, and external validation using synthetic and pharmaceutical preparations. The proposed method was applied for analysis of two pharmaceutical products. Both pharmaceutical products had the same active principle and similar excipients, but with different nominal concentration values. The results of the proposed method were compared with the results of a pharmacopoeial method for the same pharmaceutical products. No significant differences between the results were found. The standard error of prediction was 0.004 for CH, 0.003 for GO, and 0.005 for AS. The correlation coefficient was 0.9998 for CH, 0.9999 for GO, and 0.9997 for AS. The highly accurate and precise RNIR method can be used for QC of pharmaceutical products.

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