An effective stability indicating RP-HPLC method for simultaneous estimation of Dolutegravir and Lamivudine in bulk and their tablet dosage form

Abstract

Abstract Background A Simple, sensitive, and specific stability indicating reverse phase HPLC method was developed for simultaneous estimation of Lamivudine and Dolutegravir in bulk and tablet dosage form. Effective separation was achieved by injecting10 μL of the standard solution into Xbridge Phenyl (250 × 4.6 mm, 5 μ,100 A0) column, using a mobile phase composition of methanol: buffer (0.1% v/v trifluoroacetic acid in water) (85:15 v/v) and isocratic elution programming have been done at a flow rate of 0.8 mL/min. The eluted analytes detected at 258 nm wavelength. The stress conditions such as acid, base, oxidative, thermal, and photo stability were applied as per ICH guidelines to determine the stability of the drugs in different environmental conditions. Results The retention times of Lamivudine and Dolutegravir were found to be 3.4 and 5.0 min respectively. The developed method was linear in the concentration range of 5–15 μg/mL and 30–90 μg/mL for Dolutegravir and Lamivudine respectively. Detection and quantification limits were observed at 3.6 and 11 μg/mL for Lamivudine and 0.50 and 1.5 μg/mL for Dolutegravir. Method validation parameters were within the acceptance criteria of ICH guidelines, and the degradation products were well resolved from Dolutegravir and Lamivudine peaks, which indicate the stability of the method. Conclusion The developed RP-HPLC method was highly precise, specific, sensitive, and stability indicating. Hence, the method has the ability to use in quality control department for regular analysis for the estimation of Lamivudine and Dolutegravir.

Keywords

• Dolutegravir
• Lamivudine
• Isocratic elution
• Stability indicating