Volume : 13, Issue : 01, January – 2026
Title:
METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DOLUTEGRAVIR AND LAMIVUDINE IN PURE SUBSTANCES AND MARKETED PHARMACEUTICAL DOSAGE FORM BY RP-HPLC
Authors :
K. Suneetha*, Matta Anjali, K. Vanitha Prakash
Abstract :
A reverse phase liquid chromatographic method for estimation of Dolutegravir and Lamivudine in bulk drugs and marketed pharmaceutical dosage form was developed and validated. The chromatographic conditions to achieve the highest performance parameters using Altima C18 (4.6×150mm, 5.0 µm) Column with guard filter were optimized. The separation was carried out using a mobile phase containing Methanol: TEA Buffer pH 4.5: Acetonitrile was taken in the ratio of 50: 25: 25% v/v/v pumped at a flow rate of 1.0 mL/min with detection at 225 nm. The method was shown to be linear in 5–25 μg/mL and 12.5–50 μg/mL concentration range (regression coefficients of 0.9993 and 0.9995) for Dolutegravir and Lamivudine respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.2μg/mL and 0.8μg/mL & 2.3μg/mL and 7.04μg/mL for Dolutegravir and Lamivudine respectively. The accuracy of the method was assessed by adding fixed amount of pre-analyzed sample to different standard solutions (50%, 100%, and 150% of the tested concentration) in triplicate. The percentage mean recoveries were found to 98%-102%. The method was found to be precise with %RSD value was found to be within the limits for intraday and interday precision study, respectively. The method specificity and robustness were also established. New and sensitive RP-HPLC method for estimation of Dolutegravir and Lamivudine has been developed, in respect to the reviewed analytical methods.
Key Words: Dolutegravir and Lamivudine, RP-HPLC, Accuracy, Precision, Robustness.
Cite This Article:
Please cite this article in press K. Suneetha et al., Method Development And Validation For The Simultaneous Estimation Of Dolutegravir And Lamivudine In Pure Substances And Marketed Pharmaceutical Dosage Form By RP-HPLC, Indo Am. J. P. Sci, 2026; 13(01).
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