METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ENTECAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC


Swathi P., S. Vidyadhara, R. L. C. Sasidhar, K. Kalyan Chakravarthi

Abstract


Objective: The objective and purpose of the analysis have sensibly assessed by selecting of a rapid and sensitive RP-HPLC method for Entecavir in bulk and pharmaceutical dosage form by using the most commonly employed C-18column with UV detection.

Methods: In estimation by RP-HPLC method Agilent 1120 compact LC system with variable programmable UV detector and Rheodyne injector with 20 µl fixed loop was used for the chromatographic separation. The mode of operation was isocratic with the components of a solution consisting of methanol: acetonitrile(70:30v/v) and triethanolamine (2-4drops)at the flow rate of 1.2 ml/min and run time was 10 min. Forced degradation studies were conducted to evaluate the stability and specificity of the method along with the validation parameters.

Results: Validation parameters of HPLC were found at a detection wavelength of 255 nm. Linearity was observed with the concentration range (Beer’s law range) 20-100µg/ml with R2=0.9991. Robustness with detection wavelengths 253 and 257 nm with a flow rate of 1 ml/min and 1.4 ml/min showed good results. The retention time of the drug was 2.64 min and assay showed 98.1%.

Conclusion: The proposed RP-HPLC method was validated as per the ICH Q2B Guidelines, and was found to be applicable for routine quantitative analysis of Entecavir by RP-HPLC using UV detector in pharmaceutical dosage forms. The results of linearity, precision, accuracy and specificity, were proved, that does not exceed certain specified limits. The method provides selective quantification with no interference from other formulation excipients. The proposed method was highly sensitive, reproducible, reliable, robust and specific. Therefore, this method is a simple, rapid analysis may actually be more desirable than a more complicated and time-consuming process. The degradation studies at various stress conditions like thermal and hydrolytic, drug gets degraded at a temperature of 80 °c and refluxing with water at 70 °c for 24hours.

 


Keywords


RP-HPLC, Entecavir, Validation, Forced degradation

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About this article

Title

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ENTECAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

Keywords

RP-HPLC, Entecavir, Validation, Forced degradation

DOI

10.22159/ijcpr.2017v9i5.22151

Date

21-09-2017

Additional Links

Manuscript Submission

Journal

International Journal of Current Pharmaceutical Research
Vol 9, Issue 5 (Aug-Sep), 2017 Page: 107-111

Online ISSN

0975-7066

Statistics

36 Views | 32 Downloads

Authors & Affiliations

Swathi P.
NRK and KSR Gupta College of Pharmacy, Tenali, Andhra Pradesh,
India

S. Vidyadhara
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh
India

R. L. C. Sasidhar
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh
India

K. Kalyan Chakravarthi
NRK and KSR Gupta College of Pharmacy, Tenali, Andhra Pradesh,
India


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