A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products

2016 ◽  
pp. 133-158 ◽  
Author(s):  
Rodolfo J. Romañach ◽  
Andrés D. Román-Ospino ◽  
Manel Alcalà
Keyword(s):  
Near Infrared ◽  
Pharmaceutical Products

scholarly journals Near-infrared spectral imaging for quality assurance of pharmaceutical products: Analysis of tablets to assess powder blend homogeneity

2002 ◽  
Vol 3 (3) ◽  
pp. 1-15 ◽  
Author(s):  
Robbe C. Lyon ◽  
David S. Lester ◽  
E. Neil Lewis ◽  
Eunah Lee ◽  
Lawrence X. Yu ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Near Infrared ◽  
Spectral Imaging ◽  
Pharmaceutical Products ◽  
Powder Blend ◽  
Products Analysis ◽  
Infrared Spectral

Raman Signal Enhancement in Deep Spectroscopy of Turbid Media

2007 ◽  
Vol 61 (8) ◽  
pp. 845-854 ◽  
Author(s):  
P. Matousek
Keyword(s):  
Raman Spectroscopy ◽  
Laser Radiation ◽  
Laser Beam ◽  
Near Infrared ◽  
Optical Element ◽  
Disease Diagnosis ◽  
Pharmaceutical Products ◽  
Turbid Media ◽  
Raman Signal

A new, passive method for enhancing spontaneous Raman signals for the spectroscopic investigation of turbid media is presented. The main areas to benefit are transmission Raman and spatially offset Raman spectroscopy approaches for deep probing of turbid media. The enhancement, which is typically several fold, is achieved using a multilayer dielectric optical element, such as a bandpass filter, placed within the laser beam over the sample. This element prevents loss of the photons that re-emerge from the medium at the critical point where the laser beam enters the sample, the point where major photon loss occurs. This leads to a substantial increase of the coupling of laser radiation into the sample and consequently an enhanced laser photon–medium interaction process. The method utilizes the angular dependence of dielectric optical elements on impacting photon direction with its transmission spectral profile shifting to the blue with increase in the deviation of photons away from normal incidence. This feature enables it to act as a unidirectional mirror passing a semi-collimated laser beam through unhindered from one side, and at the other side, reflecting photons emerging from the sample at random directions back into it with no restrictions to the detected Raman signal. With substantial restrictions to the spectral range, the concept can also be applied to conventional backscattering Raman spectroscopy. The use of additional reflective elements around the sample to enhance the Raman signal further is also discussed. The increased signal strength yields higher signal quality, a feature important in many applications. Potential uses include sensitive noninvasive disease diagnosis in vivo, security screening, and quality control of pharmaceutical products. The concept is also applicable in an analogous manner to other types of analytical methods such as fluorescence or near-infrared (NIR) absorption spectroscopy of turbid media or it can be used to enhance the effectiveness of the coupling of laser radiation into tissue in applications such as photodynamic therapy for cancer treatment.

Determination of enantiomeric compositions of pharmaceutical products by near-infrared spectrometry

2004 ◽  
Vol 325 (2) ◽  
pp. 206-214 ◽  
Author(s):  
Chieu D. Tran ◽  
Daniel Oliveira ◽  
Victor I. Grishko
Keyword(s):  
Near Infrared ◽  
Pharmaceutical Products ◽  
Infrared Spectrometry ◽  
Near Infrared Spectrometry

Reflectance Near-Infrared Spectroscopic Method with Chemometric Techniques for Simultaneous Determination of Chondroitin, Glucosamine, and Methyl Sulfonyl Methane

2012 ◽  
Vol 95 (4) ◽  
pp. 1035-1042
Author(s):  
Alaa El-Gindy ◽  
Khalid Abdel-Salam Attia ◽  
Mohammad Wafaa Nassar ◽  
Hamed Hamed Abu Seda ◽  
Maisra Al-Shabrawi
Keyword(s):  
Simultaneous Determination ◽  
Near Infrared ◽  
Spectroscopic Method ◽  
External Validation ◽  
Pharmaceutical Preparations ◽  
Principal Component ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Calibration Model

Abstract Reflectance near-IR (RNIR) spectroscopy was used for the simultaneous determination of chondroitin (CH), glucosamine (GO), and methyl sulfonyl methane (MSM) in tablets. Simple sample preparation was done by grinding, sieving, and compression of the tablets for improving RNIR spectra. Principal component regression and partial least squares (PLS-1 and PLS-2) were successfully applied to quantify the three components in the studied mixture using information included in RNIR spectra in the range of 4350–9100 cm–1. The calibration model was developed with drug concentration ranges of 14.5–44.2% (w/w) for CH, 18.4–55.3% (w/w) for GO, and 6–18.6% (w/w) for MSM with addition of tablet excipients to the calibration set in the same ratio as in the tested tablets. The calibration models were evaluated by internal validation, cross-validation, and external validation using synthetic and pharmaceutical preparations. The proposed method was applied for analysis of six batches of the pharmaceutical product. The results of the proposed method were compared with the results of the pharmacopoeial method for the same batch of the pharmaceutical product. No significant differences between the results were found. The RNIR method is accurate and precise, and can be used for QC of pharmaceutical products.

scholarly journals Near-infrared spectroscopy for the detection and quantification of bacterial contaminations in pharmaceutical products

2015 ◽  
Vol 492 (1-2) ◽  
pp. 199-206 ◽  
Author(s):  
Cristina Quintelas ◽  
Daniela P. Mesquita ◽  
João A. Lopes ◽  
Eugénio C. Ferreira ◽  
Clara Sousa
Keyword(s):  
Infrared Spectroscopy ◽  
Near Infrared Spectroscopy ◽  
Near Infrared ◽  
Pharmaceutical Products ◽  
Detection And Quantification

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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