Shah S A, Shah D R, Chauhan R S, Jain J R
Department of Quality Assurance, Maliba Pharmacy College, Bardoli-Mahuva Road, Tarsadi, Dist. Surat-394 350, India.
Indian J Pharm Sci. 2011 May;73(3):296-300. doi: 10.4103/0250-474X.93520.
Two simple spectrophotometric methods have been developed for simultaneous estimation of drotaverine hydrochloride and aceclofenac from tablet dosage form. Method I is a simultaneous equation method (Vierodt's method), wavelengths selected are 306.5 and 276 nm. Method II is the absorbance ratio method (Q-Analysis), which employs 298.5 nm as λ(1) and 276 nm as λ(2) (λmax of AF) for formation of equations. Both the methods were found to be linear between the range of 8-32 μg/ml for drotaverine and 10-40 μg/ml for aceclofenac. The accuracy and precision were determined and found to comply with ICH guidelines. Both the methods showed good reproducibility and recovery with % RSD in the desired range. The methods were found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of drotaverine and aceclofenac in their combined tablet dosage form.
已开发出两种简单的分光光度法，用于同时测定片剂剂型中盐酸屈他维林和醋氯芬酸的含量。方法I是联立方程法（维罗德特法），所选波长为306.5和276nm。方法II是吸光度比值法（Q分析），它采用298.5nm作为λ(1)，276nm作为λ(2)（醋氯芬酸的λmax）来构建方程。两种方法在盐酸屈他维林浓度为8 - 32μg/ml、醋氯芬酸浓度为10 - 40μg/ml范围内均呈线性。测定了准确度和精密度，结果符合ICH指南。两种方法均具有良好的重现性和回收率，相对标准偏差（%RSD）在预期范围内。这些方法快速、特异、精密且准确，可成功应用于其复方片剂剂型中盐酸屈他维林和醋氯芬酸的常规分析。
