Analysis Of The Uniformities Of Compound Sulfamethoxazole Tablets With Fourier Transform Near Infrared Spectroscopy

Compound sulfamethoxazole tablets are mainly used in the treatment ofurinary tract infection, upper respiratory tract infection, pneumocystis cariniipneumonia and so on. Due to the wide clinical application and the simplerproduction process of compound sulfamethoxazole tablets, a lot of factoriesin our country manufacture this drug. Nonethless, the quality uniformities ofcompound sulfamethoxazole tablets between manufacturers, betweenbatches and within one batch are different, because of the difference of rawmaterials, production process, production status et al. Therefore, analysisand control of the quality uniformity of compound sulfamethoxazole tabletsbecome an important issue.The existing methods for the analysis of the drugs quality uniformitymainly include visual method and high performance liquid chromatography(HPLC) fingerprint method. These methods are subjective, one-sided,tedious or time-consuming, so they are not available for process analysis andon-line analysis. However, near infrared spectroscopy (NIRS) has theadvantages of nondestructive, rapid and so on. In addition, near infrared spectra contain the abundant samples information, which can accomplishhigh-throughput analysis for the complex system when combine withchemometric techniques.In this study, Fourier transform near infrared spectroscopy (FT-NIRS)combines with discriminant analysis (DA), principal component analysis(PCA) and generalized variance analysis (GVA) to establish anondestructive and rapid analytical method for analysis of the uniformitiesof compound sulfamethoxazole tablets. The proposed strategies couldprovide technical supports for improving the drug quality, strengtheningsupervision, and preserving the rights and interests of consumers andmanufacturers.OBJECTIVE:To establish a nondestructive and rapid analytical method for theuniformities of compound sulfamethoxazole tablets between manufacturers,between batches and within one batch with NIRS.METHODS:1. Measurement of spectra of compound sulfamethoxazole tabletsThe near infrared diffuse reflectance spectra (NIRDRS) of compoundsulfamethoxazole tablets were measured by Fourier transform near infraredanalyzer with diffuse reflectance accessory. The measurement conditions: aresolution of8cm-1, scans of64and the scan range of10000–4000cm-1.2. Establishment of analytical methods for the uniformities of compound sulfamethoxazole tablets(1) Basic on the NIRDRS of compound sulfamethoxazole tablets, theuniformity between manufacturers was analyzed by DA and GVA,respectively.(2) Basic on the NIRDRS of compound sulfamethoxazole tablets, theuniformity between batches was analyzed by PCA and GVA, respectively.(3) Basic on the NIRDRS of compound sulfamethoxazole tablets, theuniformity within one batch was analyzed by PCA and GVA, respectively.RESULTS:1. Uniformity between manufacturers: the DA model could accuratelyidentify the manufacturer of compound sulfamethoxazole tablets, whichindicated the uniformity between manufacturers was bad; moreover, thegeneralized variance (GV) value was available for quantitativecharacterization of the uniformity between manufacturers.2. Uniformity between batches: both PCA and GVA could availablyanalyze the uniformity of compound sulfamethoxazole tablets betweenbatches, the uniformity between batches of manufacturer A was better thanthat of manufacturer B and C. Besides, comparing the GV value of betweenmanufacturers and the GV values of between batches, the result showed thatthe uniformity of compound sulfamethoxazole tablets between batches wasbetter than the uniformity between manufacturers.3. Uniformity within one batch: both PCA and GVA could availably analyze the uniformity of compound sulfamethoxazole tablets within onebatch, the results showed that the uniformity of batch “B1” was worst, andthe amount of variation for within one batch uniformities of manufacturer Awas smallest. Besides, comparing the GV values of between-manufacturers,between-batches and within-batch, the result showed that the uniformity ofcompound sulfamethoxazole tablets within one batch was similar with theuniformity between batches, and it was better than the uniformity betweenmanufacturers.CONCLUTION:NIRS could accurate, nondestructive and rapid analysis of theuniformities of compound sulfamethoxazole tablets between manufacturers,between batches and within one batch. The proposed strategy could be usedin the uniformity control of tablets in governmental management and inmanufacture process.