Bhole, Ritesh P.; Naksakhare, Sachin R.; Bonde, Chandrakant G. published the artcile< A stability indicating HPTLC Method for apremilast and identification of degradation products using MS/MS>, Electric Literature of 608141-42-0, the main research area is apremilast degradation product high performance liquid chromatog pharmaceutical formulation.
Aim: Apremilast is used for treatment of certain types of psoriasis, psoriatic arthritisand plaque psoriasis is a type of skin condition. An extensive literature search revealed that there exist very few methods on RP-HPLC reported and HPTLC method was not reported. This study deals with simple, precise, accurate and economical stability indicating HPTLC method development with validation as per ICH guidelines with application of developed method on in Apremilast pharmaceutical formulations and Identified and Characterization of degradation products using MS/MS. Method: Precoated Silica gels plates were used as stationary phase. Toluene: Et Acetate (4:6; volume/volume) was delivered best separation at 236 nm (Rf 0.55 ± 0.02) by densitometry anal. Degradation anal. was performed as per ICH guidelines (Q2R1). Isolation of degradation product by HPTLC method and identify by MS/MS method. Results: The linearity was 100-600 ng with R2 of 0.997 while, % RSD was in range. LOD and LOQ of Apremilast were found 0.77ng/spot and 2.35ng/spot resp. The recovery of Apremilast was found to be 99.70 ± 0.23%. The % assay of active substance was found in a range 80.62 to 100. HPTLC and MS/MS method revealed possible degradation mechanism of 11 degradant products. Conclusion: The Proposed developed and validated HPTLC method was found to be more sensitive, simple, precise, accurate, cost effective and robust. This method could be applied for anal. of bulk drug and tablet formulation, degradation study. This degradation pathway of drug will help to identify the degradation products of Apremilast.
Journal of Pharmaceutical Sciences and Research published new progress about HPLC. 608141-42-0 belongs to class ethers-buliding-blocks, and the molecular formula is C12H19NO4S, Electric Literature of 608141-42-0.
Referemce:
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Ether | (C2H5)2O – PubChem