Enrofloxacin is a fluoroquinolone for veterinary use; it has low aqueous solubility and relatively high permeability. Dissolution may be the limiting step in absorption for solid dosage forms having these characteristics. Considering this, in vitro dissolution tests are indicated to evaluate batch-to-batch quality and to support pharmaceutical equivalence studies. In this study, an alternative dissolution profile was developed for tablets containing enrofloxacin. The selected method uses a 0.01 N HCl medium, paddle apparatus, and 50-rpm speed. The samples were analyzed by UV spectroscopy at 273 nm. The results confirm that the proposed method is suitable for routine quality control of enrofloxacin tablets and the comparison of the dissolution profiles of different commercial formulations.
Interval partial least-squares calibration (iPLS) and synergical partial least-squares calibration (siPLS) methods in combination with near infrared spectroscopy coupled with integrating sphere (NIRA) have been developed for simultaneous determination of amlodipine (AML), valsartan (VAL) and hydrochlorothiazide (HCT) in raw material powder mixtures used for production commercial pharmaceutical product (tablets). Variable selection methods (iPLS and siPLS) were applied to select a spectral range that provided significant information and models with lower prediction errors. A near-infrared reflectance accessory (NIRA) was used for direct sample analysis. Spectral data were acquired between 10000 -4000 cm -1 and divided into 32 intervals. A relative standard error of prediction of 1.27% for VAL, 1.92% for HCT and 5.19% for AML was obtained after selection of better intervals by siPLS. Results shown that variable selection methods associated to NIRA is a relatively simple, free solvent and non-destructive procedure that could be applied to the simultaneous determination of AML, VAL and HCT in tablets.
Analytical techniques based on Ultraviolet (UV) spectrophotometry are widely used in pharmaceutical analysis, because they are simple and inexpensive. The choice of pH is critical in the development of univariate methods for pharmaceutical quantitation by UV spectrophotometry since changes may modify the absorption spectrum profile. Similar to univariate methods by UV spectrophotometry changes in pH may influence the predictive ability of multivariate models, affecting the resultant analytical performance. We report herein on the influence of pH on the simultaneous determination of sulfamethoxazole (SMZ) and trimethoprim (TMP) in tablets using UV spectrophotometry and multivariate calibration. Data were recorded using a UV spectrophotometer in the wavelength range of 200 to 350 nm. The experimental matrix was constructed using 36 synthetic samples of SMZ-TMP mixtures. The concentration ranges used for the investigation were 14.0 to 26.0 mg L-1 for SMZ and 2.8 to 5.2 mg L-1 for TMP. The Partial Least Squares (PLS) regression models were generated with full-spectrum and multiple pH levels. At pH 4.3, lower values of relative standard error of prediction (RSEP %) for SMZ (1.83) and TMP (1.13) were obtained. The PLS model at pH 4.3 was used for the quantification of real samples (tablets obtained from 13 different manufacturers) and the results were compared with conventional procedures using high performance liquid chromatography (HPLC).
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