DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD FOR THE SIMULTANEOUS ESTIMATION OF LAMIVUDINE, STAVUDINE AND EFAVIRENZ IN PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC
Gorja Ashok* and Sumanta Mondal
ABSTRACT
A stability indicating method was developed for the simultaneous estimation of Lamivudine, Stavudine and Efavirenz in pharmaceutical dosage form by reverse phase high performance liquid chromatography (RP-HPLC) and validated. The chromatographic separation was performed using the Kromasil C18 (250mm × 4.6mm, 5μ) column run in an isocratic mode with a flow rate of 1mL/min at ambient temperature. The mobile phase consists of 0.1% O-Phosphoric acid, Acetonitrile and Methanol in the ratio 70:20:10 (v/v/v/) and detected at the wave length 226nm. The retention times for Lamivudine, Stavudine and Efavirenz were found to be 2.39min, 3.06min and 3.53min respectively. The drugs obeyed Beer’s law in the concentration range of 18.75μg/mL – 112.50μg/mL, 5μg/mL – 30μg/mL and 75μg/mL – 450μg/mL respectively. The method was validated as per ICH guidelines for accuracy, precision, specificity, ruggedness, robustness and stability. The standard solution was subjected to stress conditions such as acidic, basic, oxidative, neutral, photolytic and thermal conditions. The degradation was found to be within the limits.
Keywords: Lamivudine, Stavudine, Efavirenz, Stability indicating, Method development, Validation, RP-HPLC.
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