Abstract:
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, whereas 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). The Retention time obtained were 2.16min for
LAM, 2.65min for TEN and 3.25min for DOR. The correlation
coefficient was found to be 0.9999 and this method is utilized for, the
chemical analysis of drugs in synthetic mixtures and in formulation.
The Stability & forced-degradations studies are carried out in the
different stress conditions and the impurities as well as pure drug
substances are efficiently detected by the developed HPLC method.The application of this HPLC method in the in vitro dissolution for the
tablet dosage forms of these three drugs can be analysed, rapidly in
this single HPLC method.
Description:
The authors gratefully thanks the contributors and co-workers in this research
work, and under the guidance of Dr Samixa Patel without their support and
knowledge it would be a difficult task. The authors are also thankful to the
industrial support from Sava group, Bizotech and Solesom pharma for providing
materials, chemicals, equipments and instrumentation facilities for the
completion of the research.
