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Titolo:
A method for measuring potency of narasin extracts using near-IR spectroscopy
Autore:
Morris, DL; Forbes, RA;
Indirizzi:
Eli Lilly & Co, Lilly Res Labs, Indianapolis, IN 46285 USA Eli Lilly & CoIndianapolis IN USA 46285 Labs, Indianapolis, IN 46285 USA Rose Hulman Inst Technol, Terre Haute, IN 47803 USA Rose Hulman Inst Technol Terre Haute IN USA 47803 rre Haute, IN 47803 USA
Titolo Testata:
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
fascicolo: 3, volume: 24, anno: 2001,
pagine: 437 - 451
SICI:
0731-7085(200101)24:3<437:AMFMPO>2.0.ZU;2-Q
Fonte:
ISI
Lingua:
ENG
Soggetto:
INFRARED REFLECTANCE SPECTROSCOPY; PHARMACEUTICAL DOSAGE FORMS; DRUG SUBSTANCES; QUALITY-CONTROL; IDENTIFICATION; ASSAY;
Keywords:
transmission near infrared (NIR) spectroscopy; analytical method validation; narasin; multiple linear regression (MLR); pharmaceutical analysis; ionophore; chemometrics;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
24
Recensione:
Indirizzi per estratti:
Indirizzo: Forbes, RA Eli Lilly & Co, Lilly Res Labs, Indianapolis, IN 46285 USA Eli Lilly & Co Indianapolis IN USA 46285 napolis, IN 46285 USA
Citazione:
D.L. Morris e R.A. Forbes, "A method for measuring potency of narasin extracts using near-IR spectroscopy", J PHARM B, 24(3), 2001, pp. 437-451

Abstract

We present a method for extracting the active component from granulated narasin samples using chloroform with subsequent quantitation by near-infrared absorption spectroscopy (NIRS). A multiple linear regression (MLR) calibration equation was developed using a set of 41 calibration samples. The potencies obtained using NIR analysis exhibit no larger than an 8% (3.03 mg/g)error when compared to results based on the primary HPLC reference method. We estimate the detection limit using this method to be 400 ppm narasin (20 mg/g potency), and the standard deviation for five independent extractions of the same sample is approximate to 24 ppm (approximate to 1.2 mg/g potency or approximately 1%). We also present the results from a robustness study based upon a full factorial experimental design in which we varied extraction and measurement parameters. This study indicates that sample mass causes the most variation in the results. Bottle-to-bottle variations in the chloroform used for the extraction also proved significant. Variations in sample batch, number of spectral scans, and the interactions between sample batch*soneration time, no. Scans*time in NIR, and sample batch*sample mass were borderline significant. (C) 2001 Elsevier Science B.V. All lights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 31/03/20 alle ore 15:26:11