RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANIOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF LAMIVUDINE AND RALTEGRAVIR IN SOLID DOSAGE FORM


Juluri Krishna Dutta Tejaswi, R. Govinda Rajan

Abstract


Objective: A stability indicating reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of the combined tablet formulation of lamivudine (LAM) and raltegravir (RAL) in dosage forms and its API.

Methods: Chromatographic separation was achieved on inertsil ODS C18 5 µm (4.6 X 150 mm) using a mobile phase (MP) consisting of a mixture of mixed orthophosphoric acid (OPA): acetonitrile (ACN) in the ratio 50:50 v/v which was determined at 242 nm respectively. 

Results: The assay of LAM and RAL was performed with tablets, and the % assay was found to be 100.12 and 99.89 which shows that the method is useful for routine analysis. The linearity of LAM and RAL was found to be linear with a correlation coefficient of 0.998 and 0.999, which shows that the method is capable of producing good sensitivity. The retention time of LAM and RAL was 1.99 min and 4.34 min respectively; linearity range was found to lie from 15 µg/ml to 75 µg/ml for LAM, 30 µg/ml to 150 µg/ml for RAL with a correlation coefficient of 0.999 respectively. Forced degradation studies were conducted in acidic, basic, thermal, photolytic and peroxide where all the degradation peaks were monitored.

Conclusion: The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of LAM and RAL in bulk and tablet dosage form. Thus the validated economical method was applied for forced degradation study of LAM and RAL tablet.


Keywords


lamivudine, Raltegravir, Acetonitrile, Stability

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About this article

Title

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANIOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF LAMIVUDINE AND RALTEGRAVIR IN SOLID DOSAGE FORM

Keywords

lamivudine, Raltegravir, Acetonitrile, Stability

DOI

10.22159/ijap.2018v10i6.28027

Date

04-10-2018

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Articles In Press [Scheduled in Nov-Dec 2018] Page: 242-248

Online ISSN

0975-7058

Authors & Affiliations

Juluri Krishna Dutta Tejaswi
Department of Pharmaceutical Analysis, College of Pharmaceutical Sciences, Acharya Nagarjuna University, Guntur (AP), India.
India

R. Govinda Rajan
Department of Pharmaceutical Chemistry, Hindu College of Pharmacy, Amaravathi Road, Guntur (AP), India.


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