DEVELOPMENT AND VALIDATION OF COST EFFECTIVE STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF LAMIVUDINE AND TENOFOVIR
Pranali Hemraj Walthare, Snehal R. Karmankar
ABSTRACT
A simple, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for the simultaneous determination of LAMI (Lamivudine) and TFDF (Tenofovir) in tablet formulations. The chromatographic separation was achieved using a C18 column with a mobile phase consisting of a mixture of methanol and water (pH adjusted to 3.0 with phosphoric acid), and the detection was performed at 265 nm. The method showed excellent linearity for both drugs, with correlation coefficients (r²) of 0.999 for LAMI and TFDF. The validation parameters, including recovery studies, repeatability, and robustness, demonstrated high precision and accuracy for both drugs. The forced degradation studies indicated the stability of the drugs under normal conditions but revealed susceptibility to degradation under extreme stress conditions. The method was applied successfully to the assay of tablet formulations, yielding results within the acceptable range. The limit of detection (LOD) and limit of quantification (LOQ) values for LAMI and TFDF were found to be sensitive enough for routine pharmaceutical analysis. This method offers a reliable approach for the quality control of LAMI and TFDF in pharmaceutical formulations.
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