TY - JOUR ID - 9135 TI - Stability Indicating HPTLC Method of Molnupiravir and Comparative Study of Degradant with Marketed Molnupiravir Impurity- A JO - Iranian Journal of Analytical Chemistry JA - IJAC LA - en SN - 2383-2207 AU - Tekade, Mayur Sanjay AU - Patil, Pallavi M AD - Department of Pharmaceutical Quality Assurance, PES’s Modern college of Pharmacy, Nigdi, Pune Maharashtra, India AD - Department of Pharmaceutical Chemistry, PES’s Modern college of Pharmacy, Nigdi, Pune Maharashtra, India Y1 - 2022 PY - 2022 VL - 9 IS - 2 SP - 51 EP - 57 KW - Molnupiravir KW - Impurity KW - HPTLC KW - IR KW - NMR KW - Mass spectrometry DO - 10.30473/ijac.2022.64848.1241 N2 - The purpose of this study was to create, optimise, and validate a high-performance thin layer chromatographic (HPTLC) method for identifying Molnupiravir (MOL) and its impurity (IMP-MOL). (3aR,4R,6R,6aR) -6-(4-(hydroxyamino) -2-oxopyrimidin-1(2H)-yl) Molnupiravir A is 2,2 dimethyltetrahydrofuro [3,4-d][1,3]dioxol-4-yl)methyl isobutyrate (MOL IMP) Over concentration ranges of 0.1 µg/band to 0.6 µg/band and 0.02 to 0.6 µg/band, the proposed technique was employed to analyse Molnupiravir and its impurity, with mean percentage recovery of 99.92% ±1.521 and 99.28% ±2.296, respectively. This method has been done with the separation of two components and ends with the densitometric measurement of the separated peaks at 276 nm. The separation was done on silica gel HPTLC F254 plates with a Toluene: n-Butanol: Methanol: Water developing system (5:3:1.5:0.5, by volume). The MOL was kept under conditions like oxidative, hydrolytic, thermal stress, and photolytic tests that the International Conference on Harmonization (ICH) requires. In acid, alkali, and oxidative hydrolysis, the MOL was unstable, but it was not affected by acidic, heat or UV light. The alkaline degradation of Molnupiravir was studied using the proposed HPTLC approach. The degradant are separated using HPTLC method, and their structures are confirmed using IR, MS, and NMR spectrum data. UR - https://ijac.journals.pnu.ac.ir/article_9135.html L1 - https://ijac.journals.pnu.ac.ir/article_9135_b40fe7b614948053cd1e6ba819ffe314.pdf ER -