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High-flux near-infrared sensitive fast non-destructive analysis for impurities and tensile strength of tablets

A tensile strength, nondestructive analysis technology, applied in the field of rapid nondestructive testing of impurities and tensile strength in tablets, rapid detection of impurities and tensile strength in pharmaceutical tablets, to achieve the effect of low prediction error and high correlation coefficient

Inactive Publication Date: 2014-05-14
CHONGQING MEDICAL UNIVERSITY
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Problems solved by technology

[0008] Currently, there is no literature on high-throughput sensitive NIR spectroscopic analysis of impurities and tensile strength in tablets

Method used

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  • High-flux near-infrared sensitive fast non-destructive analysis for impurities and tensile strength of tablets
  • High-flux near-infrared sensitive fast non-destructive analysis for impurities and tensile strength of tablets
  • High-flux near-infrared sensitive fast non-destructive analysis for impurities and tensile strength of tablets

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Experimental program
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Effect test

Embodiment

[0033] 1. Tablet sample preparation and its NIR-DRS collection.

[0034] Reduced glutathione tablet samples (100mg / tablet) were prepared by entrusting manufacturers to change the dosage of the main drug according to the registered prescription process.

[0035] Instrument: Fourier transform near-infrared spectrometer, the sampling device is a tablet diffuse transmission sampling accessory, the signal acquisition software is Result3.0, and the data processing software is TQ Analyst8.0.

[0036] Scanning conditions: Use the integrating sphere tablet diffuse transmission sampling accessory to scan both the front and back of the tablet. Scan the background before scanning the sample.

[0037] Measurement conditions: the resolution in the NIR-DRS measurement parameters is 8cm -1 , the number of scans is 64, and the spectral range is 10000~4000cm -1 .

[0038] 2. Determine the content of oxidized glutathione impurity in the tablet sample by HPLC, as a reference value.

[0039] ...

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Abstract

The invention relates to high-flux near-infrared sensitive fast non-destructive analysis for the impurities and tensile strength of tablets, belonging to the field of analyzing pharmaceutical preparation. The high-flux near-infrared sensitive fast non-destructive analysis comprises the following steps: preparing or collecting a tablet sample; collecting the near-infrared diffusion spectroscopy (NIR-DRS) of the known tablet sample through a fourier transform near infrared spectroscope; determining the reference value of impurity content of the tablets by using high performance liquid chromatography (HPLC); determining the reference value of the tensile strength through a vernier caliper and a tablet hardness tester; preprocessing the spectrum; selecting the optimal modeling wavenumber range and rejecting singular value; respectively establishing an NIR-DRS-based impurity and tensile strength correction model and evaluating the performance of the models; collecting the NIR-DRS of the unknown tablet samples; performing preprocessing identical with that of the NIR-DRS of the known sample on the NIR-DRS of the unknown tablet sample; and predicting the impurity content and tensile strength of the unknown tablet sample by using the established models. The method is high in sensitivity, free from preprocessing of the samples, fast and non-destructive in analyzing, and accurate in results.

Description

technical field [0001] The invention relates to a method for rapidly detecting impurities and tensile strength in pharmaceutical tablets, specifically a method for rapidly and nondestructively detecting impurities and tensile strength in tablets using Fourier transform near-infrared spectroscopy combined with chemometrics technology The method belongs to the field of pharmaceutical preparation analysis. Background technique [0002] Tablet refers to a sheet-like preparation formed by uniform mixing of drugs and pharmaceutical excipients. Tablets have the advantages of convenient taking, good chemical stability, accurate dosage, and convenient carrying. At present, among the preparations recorded in the pharmacopoeias of various countries in the world, tablets are the most. [0003] During the production and storage of tablets, some impurities are often introduced, affecting the stability and curative effect of tablets, and even endangering human health. Therefore, it is n...

Claims

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Application Information

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IPC IPC(8): G01N21/359
Inventor 范琦李娟吴阮琦陈杨董艳虹王以武
Owner CHONGQING MEDICAL UNIVERSITY
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