DETERMINATION AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF MIRABEGRON IN TABLET DOSAGE FORM
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 Ã— 2.1 mm, 1.7Î¼m and Mobile Phase-Potassium di-hydrogen phosphate: acetone in the ratio (40:60 v/v) at PH6.0Â±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 30-70Î¼g/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 Âµg/ml, (n=3). The limit of detection (LOD) and limit of quantitation (LOQ) for Mirabegron were 0.01Âµg/ml and 0.05Âµg/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.
2. Skoog DA, West DM, Holes JF. Fundamentals of analytical chemistry. 7th ed. Harcourt: College Publishers; 2001. p. 1-5.
3. Sethi PD. HPLC quantitative analysis of drugs in pharmaceutical formulations. 3rd Ed. New Delhi: CBS publisher and distributors; 2001. p. 53-62.
4. Kennedy JH. Analytical Chemistry: Principles. 2nd Ed. New York: Saunders College publishing; 1990. p. 3-20.
5. Lee MS, Kerns EH. Mass Spectrum. Rev 1999;18:187.
6. Lee MS. LC-MS applications in drug development. New York, USA: John Wiley and Sons; 2002.
7. Gennaro AR, Remington: The Science and Practice of Pharmacy. 20th ed. Lippincott Williams and Wilkins; 2000. p. 587-610.
8. Kazakevich Y, LoBrutto R. HPLC for Pharmaceutical Scientists. New York, USA: A John Wiley and sons, Inc; 2007. p. 5.
9. Chusena Narasimharaju Bhimanadhuni, Devala Rao Garikapati. RPâ€“HPLC method for the determination of mirabegron in pharmaceutical dosage. Am J PharmTech Res 2012;2:564-71.
10. 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.
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.
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