Spectroscopic and Chromatographic Method Development and Validation for the estimation of Antimicrobial Agents and their combinations in Synthetic Mixture and Assay Method for the Pharmaceutical Dosage Forms

Abstract

Background: The present research work comprises of the Stability Indicating RP-HPLC newlineanalytical method development and validation for selected drugs andamp; pharmaceutical dosage newlineforms belonging to the Antimicrobial class. The antimicrobial drugs are frequently upgraded newlineand newly approved drugs by FDA and CDSCO are available in the markets in the form of newlinenew dosage forms as well as combined dosage forms with other drugs. For the newly newlineapproved drugs and their drug combinations, the Stability analytical methods are not newlineavailable in pharmacopoeia and even dissolution methods for the solid dosage forms are also newlinenot available for the combined dosage forms. Hence there is a need of newer analytical newlinemethods, as well as stability, indicating rapid- RP-HPLC technique and it is optimised for, newlineanalysis of drug during different stress conditions as well as in pure from and solid dosage newlineform along with the in-vitro dissolution studies carried out for solid dosage forms. Aim: The newlinemain aim of the present research work to develop and validate spectroscopic andamp; newlinechromatographic analytical methods for the estimation of antimicrobial agents and their newlinecombinations in synthetic mixture and assay method for the pharmaceutical dosage forms. newlineMaterials and Methods: Working Standard drugs- Doravirine, Lamivudine, Tenofovir, newlineCabotegravir, Rilpivirine, Dolutegravir, Fexinidazole, Maribavir, Molnupiravir, Amoxicillin, newlineClarithromycin, Vonoprazan, Combined formulations, Chromatographic HPLC system newlineShimadzu LC-20-AT, UV Spectrophotometer systronics andamp; shimadzu-1800, Hypersil- newlinecoloumn ODS-C18 ( 250 mm x 4.6 mm, 5 µm id), Analytical balance, sonicator, Dissolution newlineapparatus Veego Microprocessor. Results andamp; Discussions: The Stability Indicating RP-HPLC newlinemethods for selected antimicrobial drugs have been developed andamp; validated using ICH newlinerecommendations, which demonstrate its accuracy, precision andamp; robustness of the procedures. newlineThe ICH parameters Accuracy, Precision, LOD, LOQ, Linearity, Range, Selectivity were newlinesuccessfully performed