development and validation of stability indicating hplc method for simultaneous estimation of amoxicillin and clavulanic acid in injection稳定的发展和验证表明高效液相色谱法同时估计的阿莫西林和克拉维酸注入.pdfVIP

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development and validation of stability indicating hplc method for simultaneous estimation of amoxicillin and clavulanic acid in injection稳定的发展和验证表明高效液相色谱法同时估计的阿莫西林和克拉维酸注入.pdf

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development and validation of stability indicating hplc method for simultaneous estimation of amoxicillin and clavulanic acid in injection稳定的发展和验证表明高效液相色谱法同时估计的阿莫西林和克拉维酸注入

American Journal of Analytical Chemistry , 2010, 1, 95-101 doi:10.4236/ajac.2010.13013 Published Online November 2010 (http://www.SciRP.org/journal/ajac) Development and Validation of Stability Indicating HPLC Method for Simultaneous Estimation of Amoxicillin and Clavulanic Acid in Injection * Durga Mallikarjuna Rao Tippa , Narendra Singh National P.G. College , Jaunpur, India E-mail : tdmrao@yahoo.in Received September 26, 2010; revised October 24, 2010; accepted October 27, 2010 Abstract A simple, fast, precise, accurate and rugged stability indicating high performance liquid chromatography (HPLC) method has been developed for simultaneous estimation of Amoxicillin and Clavulanic acid from injectable dosage form. The stability indicating capability of the method was proven by subjecting the drugs to stress conditions as per ICH recommended test conditions such as alkaline and acid hydrolysis, oxidation, photolysis, thermal degradation and resolution of the degradation products formed therein. The separation was obtained using a mobile phase composition at a ratio of 95:5 (v/v) of pH 5.0 buffer and methanol on In- ertsil C18 column (250 × 4.0 mm, 4 μm) with UV detection at 220 nm at a flow rate of 1 ml/minute. The photodiode array detector was used for stress studies. The order of elution of peaks was Clavulanic acid fol- lowed by Amoxicillin. The linear calibration range was found to be 79.51 to 315.32 μg/ml for Amoxicillin and 17.82 to 67.90 μg/ml for Clavulanic acid. The Amoxicillin and Clavulanic acid were found to be stable in solution up to 24 hours. The method validation data showed excellent results for precision,