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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

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dc.contributor.author Pandya, Yogi
dc.contributor.author Patel, Samixa
dc.date.accessioned 2023-05-29T05:42:23Z
dc.date.available 2023-05-29T05:42:23Z
dc.date.issued 2022
dc.identifier.citation Pandya, Y., & Patel, S. (2022). 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. International Journal of Health Sciences, 6(S3), 4931–4949. https://doi.org/10.53730/ijhs.v6nS3.6993 en_US
dc.identifier.issn 2550-696X
dc.identifier.uri http://10.9.150.37:8080/dspace//handle/atmiyauni/1153
dc.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. en_US
dc.description.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. en_US
dc.language.iso en en_US
dc.publisher International Journal of Health Sciences en_US
dc.subject RP-HPLC en_US
dc.subject stability en_US
dc.subject antivirals en_US
dc.subject lamivudine en_US
dc.subject tenofovir en_US
dc.subject doravirine en_US
dc.subject in vitro dissolution en_US
dc.title 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 en_US
dc.type Article en_US


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