Department of Pharmaceutical Chemistry and Analysis, Ramanbhai Patel College of Pharmacy, CHARUSAT University, Changa, Gujarat, India.
Department of Mathematics, P.D. Patel Institute, CHARUSAT University, Changa, Gujarat, India.
Spectrochim Acta A Mol Biomol Spectrosc. 2014 May 5;125:46-52. doi: 10.1016/j.saa.2014.01.036. Epub 2014 Jan 23.
Two methods, absorption correction and multivariate spectrophotometric methods were developed for simultaneous estimation of Celecoxib (CEL) and Diacerein (DIA) in combined dosage form. Absorption correction method involves direct estimation of DIA at wavelength 341 nm in which CEL has zero absorbance and shows no interference. For estimation of CEL, corrected absorbance was calculated at 253 nm due to the interference of DIA at this wavelength. Linearity was observed in the range of 6-22 μg mL(-1) for CEL and 3-11 μg mL(-1) for DIA. The method was validated as per ICH guidelines. Chemometric methods including classical least square (CLS), inverse least square (ILS), principal component regression (PCR) and partial least square (PLS) were studied for simultaneous determination of CEL and DIA in capsule using spectrophotometry. A set of 25 standard mixtures containing both drugs were prepared in range of 5-25 μg mL(-1) for CEL and 3-15 μg mL(-1) for DIA. Analytical figure of merit (FOM), such as sensitivity, selectivity, analytical sensitivity, limit of detection and limit of quantitation were determined for chemometric methods. The proposed methods were applied for determination of two components from combined dosage form.
两种方法，吸收校正法和多元分光光度法，被开发用于同时测定复方制剂中的塞来昔布（CEL）和双醋瑞因（DIA）。吸收校正法涉及在波长 341nm 处直接测定 DIA，此时 CEL 几乎无吸收，没有干扰。对于 CEL 的测定，由于 DIA 在这个波长处的干扰，在 253nm 处计算校正后的吸光度。CEL 的线性范围为 6-22μgmL(-1)，DIA 的线性范围为 3-11μgmL(-1)。该方法符合 ICH 指南的要求。化学计量学方法，包括经典最小二乘法（CLS）、逆最小二乘法（ILS）、主成分回归（PCR）和偏最小二乘法（PLS），被用于同时测定胶囊中的 CEL 和 DIA。使用分光光度法，在 5-25μgmL(-1)范围内制备了一组 25 个含有两种药物的标准混合物，用于 CEL，在 3-15μgmL(-1)范围内制备了一组 25 个标准混合物，用于 DIA。为化学计量学方法确定了分析性能指标（FOM），如灵敏度、选择性、分析灵敏度、检测限和定量限。该方法已应用于复方制剂中两种成分的测定。
