DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF BAMIFYLLINE HYDROCHLORIDE IN TABLET DOSAGE FORM

  • Panchumarthy Ravisankar Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh, India
  • Shaheem Sulthana Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh, India
  • Inturi Mary Thanuja Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh, India
  • A. Dihitha Chowdary Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh, India
  • J. Vyshnavi Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh, India

Abstract

Objective: The objective of the current study was to develop and validate a novel RP-HPLC method for determination of bamifylline hydrochloride in pharmaceutical dosage form.

Methods: Chromatographic separation was conducted on Agilent technologies-1260 series with the G1311C quaternary pump, eclipse XDB C18 column (4.6 mm i.d. X 250 mm, 5 µm particle sizes) and equipped with photodiode array detector G1315D. Mobile phase consisted of methanol and acetonitrile were mixed in the ratio of 90:10 v/v, was used at a flow rate of 1 ml/min and detection wavelength was set at 263 nm.

Results: The retention time for bamifylline hydrochloride was found to be 2.913 min. The calibration was linear (r2= 0.9996) in the concentration range of 2-10 µg/ml. The limit of detection and the limit of quantitation were found to be 0.4825 μg/ml and 1.4621 µg/ml respectively. Recovery of bamifylline hydrochloride in tablet formulation was observed in the range of 99.6-99.8 %. Percentage assay of bamifylline hydrochloride (Bamifix) was found to be 99.4 % w/w.

Conclusion: Thus the novel proposed method for bamifylline hydrochloride was found to be feasible for the estimation of bamifylline hydrochloride in bulk as well as a pharmaceutical dosage form. 

Keywords: Bamifylline hydrochloride, RP-HPLC, Validation, ICH guidelines

References

1. Nishimura Y, Maeda H, Hashimoto A, Tanaka K, Yokoyama M. Relationship between bronchial hyperreactivity and symptoms of cardiac asthma in patients with non-valvular left ventricular failure. Jpn Circ J 1996;60:933-9.
2. Alciato P, Cantone PA, Fico D, Gagliardini R, Petrella V. Bamifylline in the therapy of asthmatic syndromes. Minerva Med 1990;81:93-7.
3. Tomai F, Crea F, Gaspardone A, Versaci F, De Paulis R, Polisca P, Chiariello L, et al. Effects of adenosine receptor blockade by bamiphylline on ischaemic preconditioning during coronary angioplasty. Eur Heart J 1996;17:846-53.
4. Ilma Nugrahani, Evalianty agiana Pertiwi, Okky Dwichandra putra. Theophylline-na-saccharine single crystal isolation for its structure determination. Int J Appl Pharm Sci 2015;7:15-24.
5. Gaganpreet Kaur, Prabhudas K, Amit Singh. Development of mucoadhesive carbohydrate heteropolymer microbeads for sustained release of theophylline. Int J Appl Pharm Sci 2015;7:295-9.
6. Carlucci G, Colanzi A, Mazzeo P. Determination of bamifylline hydrochloride impurities in bulk material and pharmaceutical forms using liquid chromatography with ultraviolet detection. J Pharm Biomed Anal 1990;8:1067-9.
7. Nicot G, Lachatre G, Gonnet C, Rocca JL. High performance liquid chromatographic method for determination of bamifylline and its three major metabolites in human plasma. J Chromatogr 1983;277:239-49.
8. Papadoyannis, Samanidou V, Zotou A. Simultaneous determination of bamifylline and its major metabolite AC-119 by RP-HPLC. J Liq Chromatogr Relat Technol 2006;16:3847-61.
9. Belliardo F, Lucarelli C. High performance liquid chromatographic method for determination of bamifylline and its major metabolite in human plasma. J Liq Chromatogr 1990;535:305-9.
10. B Patel, Mrunali R Patel, Tapan S, Goswami. Stability indicating RP-HPLC method for estimation of bamifylline hydrochloride in tablet formulation: development and validation. Thai J Pharm Sci 2014;38:168-75.
11. Gerlo E, Maes V. High performance liquid chromatographic method for assay of bamifylline in human plasma of neonates. Am Assoc Clin Chem 1988;34:1657.
12. Rashmin B, Patel, Mrunali R, Patel, Tapan S, Goswami. A new HPTLC method for estimation of bamifylline: Development and validation consideration. Int J Adv Pharm Anal 2012;2:83-7.
13. 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.
14. 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.
15. ICH Q2 (R1), Validation of analytical procedures, Text and methodology. International Conference on Harmonization, Geneva; 2005. p. 1-17.
Statistics
257 Views | 498 Downloads
How to Cite
Ravisankar, P., Sulthana, S., Thanuja, I. M., Chowdary, A. D., & Vyshnavi, J. (2017). DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF BAMIFYLLINE HYDROCHLORIDE IN TABLET DOSAGE FORM. International Journal of Applied Pharmaceutics, 9(4), 76-82. https://doi.org/10.22159/ijap.2017v9i4.19438
Section
Original Article(s)