A Concise Review Based on Analytical Method Development and Validation of Apremilast in Bulk and Marketed Dosage Form

  • Saurabh C. Khadse Dept. of Pharmaceutical Chemistry, RCPIPER, Shirpur, INDIA, 425405
  • Shailesh S. Chalikwar Dept. of Quality Assurance, RCPIPER, Shirpur, INDIA, 425405
  • Sandip D. Firke Dept. of Pharmaceutical Chemistry, RCPIPER, Shirpur, INDIA, 425405
  • Harshal Ramkrishna Baviskar Dept. of Quality Assurance, RCPIPER, Shirpur, INDIA, 425405
  • Akshay D. Umale Dept. of Quality Assurance, RCPIPER, Shirpur, INDIA, 425405

Abstract

Apremilast is used for treatment of psoriasis and psoriatic arthritis. It may also be beneficial for other inflammatory diseases relevant to the immune system. The drug functions as a selective enzyme phosphodiesterase 4 (PDE4) inhibitor and avoids the spontaneous development of TNF-alpha from human synovial rheumatoid cells. The present review assesses the different approaches for evaluation of apremilast in bulk material as well as different formulations. A concise review consists of compile and discuss about over 30 methods for analysing apremilast in the biological matrices, the samples of bulk and in different dosage formulations including HPLC, HPTLC, UPLC, LC-MS and UV-spectrophotometry. A concise review represents the compilation and discussion of about more than 30 analytical methods which includes HPLC, HPTLC, UPLC, LC-MS and UV-Spectrophotometry methods implemented for investigation of apremilast in biological matrices, bulk samples and in different dosage formulations. This detailed review will be of great help to the researcher who is working on apremilast.


Keywords: Apremilast; Analytical Profile; HPLC; HPTLC; Bioanalytical; Stability indicating

Keywords: Apremilast, Analytical Profile, HPLC, HPTLC, Bioanalytical, Stability indicating

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Author Biographies

Saurabh C. Khadse, Dept. of Pharmaceutical Chemistry, RCPIPER, Shirpur, INDIA, 425405

Dept. of Pharmaceutical Chemistry, RCPIPER, Shirpur, INDIA, 425405

Shailesh S. Chalikwar, Dept. of Quality Assurance, RCPIPER, Shirpur, INDIA, 425405

Dept. of Quality Assurance, RCPIPER, Shirpur, INDIA, 425405

Sandip D. Firke, Dept. of Pharmaceutical Chemistry, RCPIPER, Shirpur, INDIA, 425405

Dept. of Pharmaceutical Chemistry, RCPIPER, Shirpur, INDIA, 425405

Harshal Ramkrishna Baviskar, Dept. of Quality Assurance, RCPIPER, Shirpur, INDIA, 425405

Dept. of Quality Assurance, RCPIPER, Shirpur, INDIA, 425405

Akshay D. Umale, Dept. of Quality Assurance, RCPIPER, Shirpur, INDIA, 425405

Dept. of Quality Assurance, RCPIPER, Shirpur, INDIA, 425405

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1.
Khadse SC, Chalikwar SS, Firke SD, Baviskar H, Umale AD. A Concise Review Based on Analytical Method Development and Validation of Apremilast in Bulk and Marketed Dosage Form. JDDT [Internet]. 15Apr.2020 [cited 16Aug.2022];10(2-s):175-82. Available from: https://jddtonline.info/index.php/jddt/article/view/4012