Validated HPTLC method for simultaneous estimation of metoprolol succinate and ramipril in bulk drug and marketed formulation

EC clinical and medical case reports Pub Date : 2019-01-01 DOI:10.15761/cmr.1000152

Kamini Sethy, J. Rao, K. Rajeswari, K. Nagoji

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引用次数: 1

Abstract

This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous estimation of Metoprolol succinate and Ramipril as the bulk drug and in tablet dosage forms. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of Methanol: Toluene: Ethyl Acetate: Ammonia (2.5:3:5:0.7v/v/v/v). Densitometric evaluation of the separated zones was performed at 209 nm. The two drugs were satisfactorily resolved with RF values 0.67, and 0.37 for Metoprolol Succinate and Ramipril, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (2000-12000 ng/spot for Metoprolol succinate and 200–1200 ng/spot for Ramipril), precision ( intra-day RSD 0.471–1.036% and inter-day RSD 1.085–1.580% for Metoprolol Succinate and intra-day RSD 1.057–1.63% and inter-day RSD 1.024–1.746% for Ramipril,), accuracy (98.95 ± 0.16 % for Metoprolol and 98.98 ± 0.41 % for Ramipril), and specificity, in accordance with ICH guidelines. *Correspondence to: K Raja Rajeswari, Sri Venkateswara College of Pharmacy, Etcherla-532410, Srikakulum District, Andhra Pradesh, India, Email: kamini.tiki@gmail.com

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验证了高效液相色谱法同时测定原料药和市售制剂中琥珀酸美托洛尔和雷米普利的含量

建立了一种简便、精确、准确的高效液相色谱同时测定琥珀酸美托洛尔和雷米普利原料药和片剂含量的新方法。以硅胶60f254预包覆的铝板为固定相，溶剂体系为甲醇:甲苯:乙酸乙酯:氨(2.5:3:5:0.7v/v/v/v /v)，对药物进行色谱分离。在209 nm处对分离区进行密度测定。琥珀酸美托洛尔和雷米普利的RF值分别为0.67和0.37。采用线性(琥珀酸美托洛尔2000 ~ 12000 ng/点，雷米普利200 ~ 1200 ng/点)、精密度(琥珀酸美托洛尔日内RSD 0.471 ~ 1.036%，日内RSD 1.085 ~ 1.580%，雷米普利日内RSD 1.057 ~ 1.63%，日内RSD 1.024 ~ 1.746%)、准确度(美托洛尔98.95±0.16%，雷米普利98.98±0.41%)、特异性等指标评价方法的准确性和可靠性，符合ICH标准。*通信:K Raja Rajeswari, Sri Venkateswara药学院，Etcherla-532410，印度安得拉邦Srikakulum区，电子邮件:kamini.tiki@gmail.com

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EC clinical and medical case reports

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