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Comparative Study of the UV Chemometrics, Ratio Spectra Derivative and HPLC-QbD Methods for the Estimation of Their Simultaneous Estimation in Combined Marketed Formulation
Chromatographia ( IF 1.2 ) Pub Date : 2020-11-10 , DOI: 10.1007/s10337-020-03979-9
M. N. Patel , A. J. Patel , U. H. Shah , S. G. Patel

Abstract The CARISOMA™ consists of carisoprodol (CAR), paracetamol (PCM) and caffeine (CAF) used for fibromyalgia and osteoarthritis. The study discussed the comparative study of UV chemometrics (method A), ratio spectra derivative (method B) and HPLC-QbD (method C) for simultaneous estimation of the aforementioned drugs in API and marketed tablet formulation. From the listed methods, method A can estimate CAR without derivatization. Analytical figures of merit (FOM) were determined for method A. The CAR has a weak chromophoric group so diazotization was carried out and the derivatized-CAR (D-CAR) was evaluated by IR, mass and NMR; further estimated by method B simultaneously with PCM and CAF. Method C involved the application of quality by design approach for the estimation of aforesaid drugs. The calibration curves of CAR, PCM and CAF found linear in the range of 1–5 µg mL −1 , 2–10 µg mL −1 and 0.2–1 µg mL −1 for method A; 1–5 µg mL −1 , 2–10 µg mL −1 , 0.2–1 µg mL −1 for method B and 10–50 µg mL −1 , 20–100 µg mL −1 and 1.85–9.25 µg mL­ −1 for method C. Method C involved the use of C18 column and ACN: potassium dihydrogen phosphate buffer (90:10 v/v) as the mobile phase at pH 3. For resolution of drugs, the described methods were successfully applied, validated and compared statistically. Method A was found to be more acceptable due to its accuracy and simplicity.

中文翻译:

紫外化学计量学、比率光谱导数和 HPLC-QbD 方法在组合上市制剂中同时估计的比较研究

摘要 CARISOMA™ 由卡立普多 (CAR)、扑热息痛 (PCM) 和咖啡因 (CAF) 组成,用于治疗纤维肌痛和骨关节炎。该研究讨论了紫外化学计量学(方法 A)、比率光谱导数(方法 B)和 HPLC-QbD(方法 C)的比较研究,用于同时估计 API 和上市片剂配方中的上述药物。从列出的方法中,方法 A 无需衍生即可估算 CAR。测定方法 A 的分析品质因数 (FOM)。 CAR 具有弱发色团,因此进行了重氮化,并通过 IR、质量和 NMR 评估了衍生化的 CAR (D-CAR);与 PCM 和 CAF 同时通过方法 B 进一步估计。方法 C 涉及应用质量源于设计方法来估计上述药物。CAR的校准曲线,对于方法 A,PCM 和 CAF 在 1–5 µg mL -1 、2–10 µg mL -1 和 0.2–1 µg mL -1 范围内呈线性;1-5 µg mL -1 、2-10 µg mL -1 、0.2-1 µg mL -1 方法 B 和 10-50 µg mL -1 、20-100 µg mL -1 和 1.85-9.25 µg mL -1对于方法 C。方法 C 涉及使用 C18 色谱柱和 ACN:磷酸二氢钾缓冲液 (90:10 v/v) 作为流动相,pH 为 3。对于药物分离,所述方法已成功应用、验证和比较统计上。由于方法 A 的准确性和简单性,人们发现方法 A 更容易被接受。10 v/v) 作为 pH 3 的流动相。对于药物的分辨率,所描述的方法已成功应用、验证和统计比较。由于方法 A 的准确性和简单性,人们发现方法 A 更容易被接受。10 v/v) 作为 pH 3 的流动相。对于药物的分辨率,所描述的方法已成功应用、验证和统计比较。由于方法 A 的准确性和简单性,人们发现方法 A 更容易被接受。
更新日期:2020-11-10
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