DEVELOPMENT AND VALIDATION OF HPLC-DAD METHOD FOR THE DETERMINATION OF BISOPROLOL IN TABLET DOSAGE FORMS
Keywords:Bisoprolol, High-Performance Liquid Chromatography, Validation, ICH guidelines
Objective: A rapid, simple and sensitive RP-HPLC method was developed and validated for the determination of bisoprolol fumarate in bulk and pharmaceutical dosage form.
Methods: Chromatographic separation was achieved within 2.5 min on ACQUITY Arc System, Waters Symmetry C18 column (3.9 mm i.d. X 150 mm, 5 Î¼m particle sizes) using a mobile phase consisted of acetonitrile: phosphate buffer (25:75 v/v) in an isocratic mode at a flow rate of 1.4 ml/min. The pH of the mobile phase was adjusted to 7.0 with orthophosphoric acid and UV detection was set at 226 nm.
Results: The retention time for bisoprolol fumarate was found to be 2.09 min. The proposed method was validated according to ICH guidelines with respect to linearity, specificity precision, accuracy and robustness. The limit of detection and limit of quantification are calculated and found to be 0.4825 and 1.4621 Î¼g/ml; respectively.
Conclusion: The proposed method can help research studies, quality control and routine analysis with lesser resources available. The results of the assay of pharmaceutical formulation of the developed method are highly reliable and reproducible and is in good agreement with the label claim of the medicines.
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Ulu ST, Kel E. Spectrophotometric determination of bisoprolol in pharmaceutical preparations by charge transfer reactions. Opt Spektrosk 2012;112:864â€“7.
Kumbhar ST, Shinde PP, Shinde DB, Solankar PB. Visible spectrophotometric method for estimation of bisoprolol from its bulk and tablet formulation. Asian J Pharm Clin Res 2013;6:103â€“5.
Kakde RB, Kotak VH, Barsagade AG, Chaudhary NK, Kale DL. Spectrophotometric method for simultaneous estimation of amlodipine besylate and bisoprolol fumarate Ã®n pharmaceutical preparations. Res J PharmTech 2008;1:513-5.
Sahu R, Patel VB. Simultaneous spectrophotometric estimation of hydrochlorothiazide and bisoprolol fumarate in combined dosage forms. Indian J Pharm Sci 2006;68:764-7.
Arjun G, Sathis KD, Bindu MB, Naga MM, Ramalingam R, RavinderNath A. A simple HPLC method for quantitation of bisoprolol fumarate in tablet dosage form. Indian Drugs 2009;46:39â€“42.
Yadav SS, Rao JR. Simultaneous HPTLC analysis of bisoprolol fumarate and hydrochlorthiazide in pharmaceutical dosage form. Int J Pharm Pharm Sci 2013;5:286â€“90.
Joshi SJ, Karbhari PA, Bhoir SI, Bindu KS, Das C. RP-HPLC method for simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide in tablet formulation. J Pharm Biomed Anal 2010;52:362â€“71.
Shaikh S, Thusleem OA, Muneera MS, Akmal J, Kondaguli AV, Ruckmani K. A simple and rapid high-performance liquid chromatographic method for the determination of bisoprolol fumarate and hydrochlorothiazide in a tablet dosage form. J Pharm Biomed Anal 2008;48:1055-7.
Patel LJ, Suhagia BN, Shah PB, Shah RR. Simultaneous estimation of bisoprololfumarate and hydrochlorothiazide in tablet dosage form by RP-HPLC method. Indian J Pharm Sci 2006;68:635-8.
Vora D, Kadav A. Development and validation of a simultaneous HPLC method for estimation of bisoprolol fumarate and amlodipine besylate from tablets. Indian J Pharm Sci 2008;70:542â€“6.
Bozal B, Gumustas M, Dogan-Topal B, Uslu B, Ozkan SA. Fully validated simultaneous determination of bisoprololfumarate and hydrochlorothiazide in their dosage forms using different voltammetric, chromatographic, and spectrophotometric analytical methods. J AOAC Int 2013;96:42-51.
Raul SK, Aravelli AB, Jhansi D. RP-HPLC method development and validation for the simultaneous estimation of atorvastatin and ezetimibe in pharmaceutical dosage form. Asian J Pharm Clin Res 2015;8:178-81.
ICH Q2 (R1), Validation of analytical procedures, Text and methodology. International Conference on Harmonization, Geneva; 2005. p. 1-17.
Patel R, Patel M, Dubey N, Dubey N, Patel B. HPTLC method development and validation: strategy to minimize methodological failures. J Food Drug Anal 2012;20:561-71.
Ravisankar P, Naga Navya Ch, Pravallika D, Navya Sri D. A review on step-by-step analytical method validation. IOSR J Pharm 2015;5:7-19.