Determination and Validation of Nimesulide in Pharmaceutical Formulation by Near Infrared Spectroscopy

被引:19
作者
Rocha, Werickson F. C. [1 ]
Rosa, Andre Luis [2 ]
Martins, Jose Antonio [2 ]
Poppi, Ronei Jesus [1 ]
机构
[1] Univ Estadual Campinas, Inst Chem, BR-13083970 Campinas, SP, Brazil
[2] Inst Vita Nova, BR-13186481 Hortolandia, SP, Brazil
关键词
near-infrared spectroscopy; nimesulide; figures of merit; net analyte signal; NET ANALYTE SIGNAL; DETECTION LIMITS; MULTIVARIATE; FIGURES; MERIT;
D O I
10.1590/S0103-50532010001000019
中图分类号
O6 [化学];
学科分类号
0703 ;
摘要
The determination of nimesulide in pharmaceutical formulation in the range of 10.38 to 39.47% m/m using near infrared spectroscopy and multivariate calibration based on partial least squares (PLS) and net analyte signal (NAS) was studied and validated by establishing its figures of merit. Suitable results were obtained, with limit of detection of 0.61%, limit quantification of 2.03%, accuracy estimated as root mean square error of prediction (RMSEP) of 1.05%, mean selectivity of 0.006, sensitivity of 0.004%, inverse analytical sensitivity of (0.20%)(-1) and signal-to-noise ratio of 181. In addition, it was obtained relative errors lower than 10% that are acceptable values for quality control of this drug. These results indicate that the proposed method can be used in pharmaceutical industries as an alternative to standard analytical procedures.
引用
收藏
页码:1929 / 1936
页数:8
相关论文
共 23 条
[1]  
Alvarez-Lueje A, 1998, ANAL LETT, V31, P1173
[2]  
[Anonymous], 2000, ANN BOOK ASTM STAND
[3]   Detection limits in classical multivariate calibration models [J].
Boqué, R ;
Faber, NKM ;
Rius, FX .
ANALYTICA CHIMICA ACTA, 2000, 423 (01) :41-49
[4]   Multivariate detection limits estimators [J].
Boque, R ;
Rius, FX .
CHEMOMETRICS AND INTELLIGENT LABORATORY SYSTEMS, 1996, 32 (01) :11-23
[5]   Figures of merit for the determination of the polymorphic purity of carbamazepone by infared spectroscopy and multivariate calibration [J].
Braga, JWB ;
Poppi, RJ .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2004, 93 (08) :2124-2134
[6]  
*COUNC EUR, 1997, EUR PHARM
[7]   Nomenclature in evaluation of analytical methods including detection and quantification capabilities (IUPAC Recommendations 1995) [J].
Currie, LA .
ANALYTICA CHIMICA ACTA, 1999, 391 (02) :105-126
[8]  
Faber NM, 1998, J CHEMOMETR, V12, P405, DOI 10.1002/(SICI)1099-128X(199811/12)12:6<405::AID-CEM520>3.0.CO
[9]  
2-8
[10]   Improved calculation of the net analyte signal in inverse multivariate calibration [J].
Ferré, J ;
Brown, SD ;
Rius, FX .
JOURNAL OF CHEMOMETRICS, 2001, 15 (06) :537-553