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

Panchumarthy Ravisankar; Shaheem Sulthana; Inturi Mary Thanuja; A. Dihitha Chowdary; J. Vyshnavi

doi:10.22159/ijap.2017v9i4.19438

Authors

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

DOI:

https://doi.org/10.22159/ijap.2017v9i4.19438

Keywords:

Bamifylline hydrochloride, RP-HPLC, Validation, ICH guidelines

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 Âµm 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 Âµg/ml. The limit of detection and the limit of quantitation were found to be 0.4825 Î¼g/ml and 1.4621 Âµg/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.Â

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