紫外-可见分光光度法同时测定固体剂型中乙哌立松和对乙酰氨基酚的方法开发与验证
Development and Validation of UV-Visible Spectrophotometric Method for Simultaneous Determination of Eperisone and Paracetamol in Solid Dosage Form.
作者信息
Khanage Shantaram Gajanan, Mohite Popat Baban, Jadhav Sandeep
机构信息
Department of Pharmaceutical Chemistry and PG studies, M.E.S. College of Pharmacy, Sonai, Ahmednagar, Maharashtra, India.
出版信息
Adv Pharm Bull. 2013;3(2):447-51. doi: 10.5681/apb.2013.073. Epub 2013 Aug 20.
PURPOSE
Eperisone Hydrochloride (EPE) is a potent new generation antispasmodic drug which is used in the treatment of moderate to severe pain in combination with Paracetamol (PAR). Both drugs are available in tablet dosage form in combination with a dose of 50 mg for EPE and 325 mg PAR respectively.
METHODS
The method is based upon Q-absorption ratio method for the simultaneous determination of the EPE and PAR. Absorption ratio method is used for the ratio of the absorption at two selected wavelength one of which is the iso-absorptive point and other being the λmax of one of the two components. EPE and PAR shows their iso-absorptive point at 260 nm in methanol, the second wavelength used is 249 nm which is the λmax of PAR in methanol.
RESULTS
The linearity was obtained in the concentration range of 5-25 μg/mL for EPE and 2-10 μg/mL for PAR. The proposed method was effectively applied to tablet dosage form for estimation of both drugs. The accuracy and reproducibility results are close to 100% with 2% RSD. RESULTS of the analysis were validated statistically and found to be satisfactory. The results of proposed method have been validated as per ICH guidelines.
CONCLUSION
A simple, precise and economical spectrophotometric method has been developed for the estimation of EPE and PAR in pharmaceutical formulation.
目的
盐酸乙哌立松（EPE）是一种新型强效解痉药，用于与对乙酰氨基酚（PAR）联合治疗中度至重度疼痛。两种药物均有片剂剂型，EPE和PAR的剂量分别为50mg和325mg。
方法
该方法基于Q吸收比法同时测定EPE和PAR。吸收比法用于在两个选定波长处的吸收比，其中一个是等吸收点，另一个是两种成分之一的最大吸收波长（λmax）。EPE和PAR在甲醇中的等吸收点为260nm，使用的第二个波长为249nm，这是PAR在甲醇中的λmax。
结果
EPE在5-25μg/mL浓度范围内呈线性，PAR在2-10μg/mL浓度范围内呈线性。所提出的方法有效地应用于片剂剂型中两种药物的测定。准确度和重现性结果接近100%，相对标准偏差（RSD）为2%。分析结果经统计学验证，结果令人满意。所提出方法的结果已按照国际人用药品注册技术协调会（ICH）指南进行验证。
结论
已开发出一种简单、精确且经济的分光光度法用于测定药物制剂中的EPE和PAR。
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