DETERMINATION AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF MIRABEGRON IN TABLET DOSAGE FORM
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Reverse phase high-performance liquid chromatography##common.commaListSeparator## Mirabegron##common.commaListSeparator## Potassium dihydrogen phosphate##common.commaListSeparator## Acetone##common.commaListSeparator## UV detector##article.abstract##
Objective: A reversed phase liquid chromatography was determined and validated for the estimation of Mirabegron in tablet dosage form.
Methods: The validation study of RP-HPLC showed a simple, rapid, accurate, precise, reproducible results by using a stationary phase: Waters Acquity HSS T-3 C18 (100 × 2.1 mm, 1.7μm and Mobile Phase-Potassium di-hydrogen phosphate: acetone in the ratio (40:60 v/v) at PH6.0±0.02. Detection is carried out at 243 nm using UV detector.
Results: The total chromatographic analysis time per sample was about 6 min with Mirabegron eluting at a retention time of 2.754. Tailing factor obtained from the standard injection is 1.6. Theoretical Plates obtained from the standard injection is 2736.7. The flow rate is 1 ml/min and linearity in the concentration range of 30-70μg/ml (R2=0.999). The precision was 0.4% the intermediate precision was 0.08%. The deliberately varied chromatographic conditions in the concentration range for the evaluation of robustness is 10-50 µg/ml, (n=3). The limit of detection (LOD) and limit of quantitation (LOQ) for Mirabegron were 0.01µg/ml and 0.05µg/ml respectively. The % recovery is 99.8 % with % R. SD of 0.09. The results proved that the optimized HPLC method fulfills these requirements within the ICH accepted limits.
Conclusion: The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of Mirabegron in tablet dosage form.
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Gell PGH, Coombs RRA. Clinical aspects of immunology. London: Blackwell; 1963;12:225-45.
Skoog DA, West DM, Holes JF. Fundamentals of analytical chemistry. 7th ed. Harcourt: College Publishers; 2001. p. 1-5.
Sethi PD. HPLC quantitative analysis of drugs in pharmaceutical formulations. 3rd Ed. New Delhi: CBS publisher and distributors; 2001. p. 53-62.
Kennedy JH. Analytical Chemistry: Principles. 2nd Ed. New York: Saunders College publishing; 1990. p. 3-20.
Lee MS, Kerns EH. Mass Spectrum. Rev 1999;18:187.
Lee MS. LC-MS applications in drug development. New York, USA: John Wiley and Sons; 2002.
Gennaro AR, Remington: The Science and Practice of Pharmacy. 20th ed. Lippincott Williams and Wilkins; 2000. p. 587-610.
Kazakevich Y, LoBrutto R. HPLC for Pharmaceutical Scientists. New York, USA: A John Wiley and sons, Inc; 2007. p. 5.
Chusena Narasimharaju Bhimanadhuni, Devala Rao Garikapati. RP–HPLC method for the determination of mirabegron in pharmaceutical dosage. Am J PharmTech Res 2012;2:564-71.
Raymond Van Teijingen, John Meijer, Shin Takusagawa, Marcel Van Geldren, Cas Van Den Beld, Takashi Usui. Development and validation of LC-MS/MS methods for the determination of Mirabegron and its metabolites in human plasma and their application to a clinical pharmacokinetic study. J Chromatography B 2012;887-888:102-11.
Chusena Narasimharaju Bhimanadhuni, Devala Rao Garikapati. Development and validation of gas chromatography method for the determination of residual solvents in Mirabegron. Pharm Chem 2013;5:55-60.