Acta Pharm. 2013 Sep;63(3):373-84. doi: 10.2478/acph-2013-0029.
The paper proposes a near infrared method able to directly and simultaneously quantify ascorbic acid and sodium ascorbate in powder blends for tableting and in vitamin C chewable tablets without any sample preparation. In the first step, calibration models for the quantification of ascorbic acid and sodium ascorbate in powder blends for tableting and subsequently in chewable vitamin C tablets (corresponding to 80-120 % active substance) were developed according to an experimental design with 2 variables and 5 levels. Then, using the best calibration models, the methods were fully validated in terms of recovery, precision and accuracy for both powder blends and vitamin C chewable tablets. The validated concentration range was 15.14-18.51 % for ascorbic acid and 12.06-14.49 % for sodium ascorbate in powder blends and 91.85-111.03 mg per tablet for ascorbic acid and 71.01-84.50 mg per tablet for sodium ascorbate in tablets. Validation results showed good precision and accuracy.
本文提出了一种近红外方法,能够直接和同时定量粉末混合物中的抗坏血酸和抗坏血酸钠,用于压片和维生素 C 咀嚼片,无需任何样品制备。在第一步中,根据具有 2 个变量和 5 个水平的实验设计,为片剂粉末混合物中抗坏血酸和抗坏血酸钠的定量以及随后的咀嚼维生素 C 片剂(对应于 80-120%的有效物质)开发了校准模型。然后,使用最佳校准模型,针对粉末混合物和维生素 C 咀嚼片,对回收率、精密度和准确度进行了全面验证。在粉末混合物中,抗坏血酸的验证浓度范围为 15.14-18.51%,抗坏血酸钠的验证浓度范围为 12.06-14.49%,每片抗坏血酸的验证浓度范围为 91.85-111.03mg,每片抗坏血酸钠的验证浓度范围为 71.01-84.50mg。验证结果表明精密度和准确度良好。