Development and Validation of RP-HPLC Methods for the Estimation of API’s in Newanti Injection and Restozeal Tablets
Journal Title: Scholars Academic Journal of Pharmacy - Year 2014, Vol 3, Issue 2
Abstract
Newanti injection comprises of 0.3 mg Biapenem in powder for injection, used as in vitro agent against anaerobes. Resveratrol is an antioxidant in Restozeal tablets. Since HPLC methods were more accurate, precise and sensitive, the present work describes two simple, precise and accurate HPLC methods for the estimation of pharmaceutical agents in Newanti injection (Method A) and Restozeal tablet dosage form (Method B). The separation was carried out using phenomenex C18 (250 x 4.6 mm, 5 µm particle size) column for both the methods. Mobile phase consisting of acetonitrile and phosphate buffer pH (6) in the ratio of 85:15%, v/v, at the flow rate of 0.8 mL/min and detection wavelength of 294 nm was chosen for method A. Acetonitrile: phosphate buffer pH (5) in the ratio of 80:20%, v/v as the mobile phase at the rate of 0.9 ml/min with the detection wavelength of 315 nm were chosen as operating parameters for Method B. The linearity range was found to be 150-350 µg/ml at the retention time of 3.33 min for biapenem; 50-100 µg/ml at 2.88 min for resveratrol. The liquid chromatography methods were extensively validated for linearity, accuracy, precision, and robustness. All these analytical validation parameters were observed to be in limits, which indicate the usefulness of the methods for determination of biapenem/resveratrol in their marketed formulations. Keywords: Biapenem, Resveratrol, Validation, RP-HPLC, Acetonitrile, Phosphate buffer (pH 6, pH 5).
Authors and Affiliations
R. Vijayalakshmi ,, Sadhik Shaik, K. Rajaskhar ,, V. S. H. Naveena, N. Aruna Kumari, M. D. Dhanaraju
Keywords
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