An Effective Stability Indicating RP-HPLC Method for Simultaneous Estimation of Lamivudine and Raltegravir in Bulk and Their Tablet Dosage Form
Gundapaneni Ravi Kumar *
Department of Analytical Chemistry, GITAM Institute of Sciences, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra Pradesh-530045, India.
Rayala Rama Rao
Department of Analytical Chemistry, GITAM Institute of Sciences, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra Pradesh-530045, India.
Vadde Megha Vardhan
Department of Analytical Chemistry, GITAM Institute of Sciences, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra Pradesh-530045, India.
V. D. N. Kumr Abbaraju
Department of Analytical Chemistry, GITAM Institute of Sciences, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra Pradesh-530045, India.
*Author to whom correspondence should be addressed.
Abstract
Background: In the current study, asimple and specific stability indicating RP-HPLC method was developed and validated for the determination of Lamivudine and Raltegravir in bulk drug and it tablet dosage form using an UV-detector. Good separation was achieved by isocratic ally on a Zorbax SB-Phenyl (150 × 4.6 mm, 3.5 μ, 80 A°) column, using a mobile phase composition of buffer (0.1% v/v Phosporic acid in water): Acetonitrile (40:60 v/v) at a flow rate of 1.0 mL/min. The eluted analytes detected at 260 nm wavelength.
Results: Lamivudine and Raltegravir were eluted at 3.1 and 5.4 min respectively with run time 7 min. Linearity in the method was measured in the concentration range of 30 – 70 μg/mL and 60 – 140 μg/mL for Lamivudine and Raltegravirrespectively. The percentage recoveries of Lamivudine and Raltegravirwere determined to be 100.30% and 100.53%, respectively. The validation of the developed method is carried as per USFDA and ICH guidelines, and the degradants were well resolved from Raltegravir and Lamivudine peaks. The developed RP-HPLC method was highly precise, specific, sensitive, and stability indicating.
Conclusion: The results of the analysis prove that thedeveloped RP-HPLC method is simple, economical and widely acceptable, which can be used in routine quality control tests in the industry.
Keywords: Lamivudine, raltegravir, isocratic elution, stability indicating