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

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

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About this article

Title

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

Keywords

Bamifylline hydrochloride, RP-HPLC, Validation, ICH guidelines

DOI

10.22159/ijap.2017v9i4.19438

Date

13-07-2017

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 9, Issue 4, 2017 Page: 76-82

Online ISSN

0975-7058

Statistics

86 Views | 86 Downloads

Authors & Affiliations

Panchumarthy Ravisankar
Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh, India
India

Shaheem Sulthana
Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh, India
India

Inturi Mary Thanuja
Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh, India
India

A. Dihitha Chowdary
Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh, India
India

J. Vyshnavi
Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh, India
India


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