Forced Degradation Analysis Of Spiramycin And Characterization Of Degradation Product By Rp-Hplc And Lc-Ms/Ms

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Rudra Prasad Adhikari , R Sangamithra , Suman Lamichhane , Aryan , S N Meyyanathan , B Babu , M Kalaivani


The objective of present work was to develop and validate forced degradation analysis and characterization of degradation products of sixteen membered lactone ring macrolide antibiotic Spiramycin under hydrolytic, oxidative, thermal and photolytic stress degradation condition as per the International Conference on Harmonization (ICH) guidelines. A simple, sensitive and accurate RP-HPLC method was developed by using C18 Water X Bridge® column (250 x 4.6 mm, 5 µm) using isocratic elution programme. The drug was found to be linear at the concentration range of 1-100 µg/ml, with a regression coefficient (r2= 0.999). Validation of developed method was performed as per ICH Q2A R1 guideline and results al all parameters were within the acceptable limit. Drug was found to degraded in hydrolytic degradation condition and was stable at oxidative, thermal and photolytic condition. A complete mass fragmentation route was established with the help of LC-MS/MS method, and data obtained from mass spectrum were employed to characterize the degradation products and structure was elucidated.

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