A novel rapid combined RP-HPLC stability method development and validation for antiviral hiv combinations lamivudine, tenofovir, doravirine in dosage form and its application to in vitro dissolution
Keywords:
RP-HPLC, stability, antivirals, lamivudine, tenofovir, doravirine, in vitro dissolutionAbstract
In the analysis of the pharmaceutical agents new sophisticated chromatographic methods have been utilized for the quality control purpose. In the current scenario ample amount of new drugs and newer pharmaceutical formulations are available intended in the cure of diseases. Diseases like HIV, AIDs , Hepatitis, and other viral diseases requires newer drugs and their combinations. As a result of this there is a need for analyse the drugs for quality control purposes. Here the api-drugs Lamivudine LAM, tenofovir TEN, Doravirine DOR, has been analysed by the RP-HPLC method in the tablet dosage-forms. This method is developed for the analysis, of these three drugs in combined forms for rapid analysis with very less amount of analytes drugs utilized for analysis purposes. The concentration range for the linearity selected was 7.5 to 45 µg/ml for Lamivudine LAM & Tenofovir TEN, where as for Doravirine DOR it is 2.5 to 15 µg/ml. Wavelength selected for estimation was 269nm and chromatographic column used was Acclaim 120 C-18 column ( 250 mm x 4.6 mm, 5 µm id ).
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