Simultaneous Determination of Clarithromycin, Tinidazole and Omeprazole in Helicure Tablets Using Reflectance Near-Infrared Spectroscopy with the Aid of Chemometry

摘要： A near infrared spectroscopic method for the simultaneous determination of the active principles clarithromycin, tinidazole and omeprazole in a pharmaceutical preparation was developed. The three active principles are quantified using partial least-squares regression methods. The proposed method is applicable over a wide analyte concentration range (80–120%) of labeled content, so it requires careful selection of the calibration set and to ensure thorough homogenization of the product. The method was validated in accordance with the ICH standard validation guidelines for NIR spectroscopy by determining its selectivity, linearity, accuracy, precision and stability. Based on the results, it is an effective alternative to the existing choice (HPLC) for the same purpose.