An Effective Stability Indicating RP-HPLC Method for Simultaneous Estimation of Lamivudine and Raltegravir in Bulk and Their Tablet Dosage Form

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.

Development and Validation of HPLC Method for the Quantification of Impending Genotoxic Impurities in Dapson Drug Substances

“…at 258 nm, 321 nm and 222 nm. The entire analysis took 65 minutes of run time[16]. mL of Acetonitrile and made 100 mg/L stock solution, 10 mg of each impurity SON-II RC-1 and SON-II standard was diluted with Acidic Acetonitrile ( 0.5% ortho-phosphoric acid (85%) in Acetonitrile) and made 100 mg/L stock solution[17], 0.1 ppm final solution made diluted with diluent (Mixture of Buffer and acetonitrile ( 40:60)).…”