A Concise Review Based on Analytical Method Development and Validation of Apremilast in Bulk and Marketed Dosage Form
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 indicatingDOI
https://doi.org/10.22270/jddt.v10i2-s.4012References
Anerao A, Telange V, Bondre N, John S, Gadhave T, Pradhan N. International Journal of Current Medical and Pharmaceutical Research.
Badhe P, Aher S, Saudagar RB. Analytical Method of Apremilast: A Review. Journal of Drug Delivery and Therapeutics. 2019 Jun 29;9(3-s):1116-9.
Rina Mohan Sonawane, Rutuja Prabhakar Sonare, Snehal Ganpat Tekawade And Dr. Ashok Pandurang Pingle. Chromatographic Method Development and Validation of Assay of Apremilast In Bulk and Tablet Dosage Form Ejbps, 2018, Volume 5, Issue 8, 412-417.
European Medicines Agency (EMA). Assessment report: Otezla. International non-proprietary name: apremilast.
Hemaraj R. Patil, Dr. S. T. Patil, V. H. Jain And Dr. S. P. Pawar. Devlopment And Validation of UV-Spectrophotometric and Hplc Method for Apremilast In Bulk and Tablet Dosage Form. Ejpmr, 2019,6(8), 233-239
Gupta V, Jain AD, Gill NS, Gupta K. Development and validation of HPLC method-a review. Int. Res J Pharm. App Sci. 2012;2(4):17-25.
Bhardwaj SK, Dwivedia K, Agarwala DD. A review: HPLC method development and validation. International Journal of Analytical and Bioanalytical Chemistry. 2015;5(4):76-81.
Thammana M. A review on high performance liquid chromatography (HPLC). Res Rev J Pharm Anal RRJPA. 2016;5(2):22-8.
Behera S, Ghanty S, Ahmad F, Santra S, Banerjee S. UV-visible spectrophotometric method development and validation of assay of paracetamol tablet formulation. J Anal Bioanal Techniques. 2012;3(6):151-7.
Jain A, Parashar AK, Nema RK, Narsinghani T. High Performance Thin Layer Chromatography (HPTLC): A Modern Analytical Tool for Chemical Analysis. Current Research in Pharmaceutical Sciences. 2014 Mar 30:8-14.
Sharma J. Chromatographic Methods of Analysis: Thin Layer Chromatography. In Encyclopedia Of Pharmaceutical Technology; Swarbrick J (Ed.), Information Healthcare (2007) (Pp. 538-550).
Reich E, Schibli A and Debatt A. Validation of High-Performance Thin-Layer Chromatographic Methods for The Identification of Botanicals in A Cgmp Environment. J AOAC Int. 2008; 91:13-20.
Renger B. Contemporary Thin Layer Chromatography in Pharmaceutical Analysis. J AOAC Int.1998; 81: 333-339.
Blessy MR, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs—A review. Journal of pharmaceutical analysis. 2014 Jun 1;4(3):159-65.
ICH Guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (Revision 2)
Patel Riddhiben M, Patel Piyushbhai M, Patel Natubhai M. Stability indicating HPLC method development-a review. International Research Journal of Pharmacy2011. 2011.
Pushpa Latha E, Sailaja B. Bioanalytical method development and validation by HPLC: a review. J Appl Pharm. 2014 Dec; 1:1-9.
Abdul Rahman MM, Kalyani Rupnawar, Madhuri A. Nagras And Supriya A. Unavane. A Review on Bioanalytical Method Development, Validation and Techniques Used for Pharmacokinetic Studies Using LCMS/MS, Contemporary Investigations and Observations in Pharmacy, 2012, 1(2), 63-71.
Pulido A, Ruisánchez I, Boqué R, Rius FX. Uncertainty of results in routine qualitative analysis. TrAC Trends in Analytical Chemistry. 2003 Oct 1;22(9):647-54.
Http://Www.Fda.Gov/Downloads/Drugs/Guidances/Ucm 070107.Pdf.
Kirthi A, Shanmugam R, Prathyusha MS, Basha DJ. A review on bioanalytical method development and validation by RP-HPLC. Journal of global trends in pharmaceutical sciences. 2014;5(4):2265-71.
Kalakuntla RR, Kumar KS. Bioanalytical method validation: A quality assurance auditor view point. Journal of Pharmaceutical Sciences and Research. 2009 Sep 1;1(3):1.
Tiwari G, Tiwari R. Bioanalytical method validation: An updated review. Pharmaceutical methods. 2010 Oct 1;1(1):25-38.
Chaudhari SR, Shirkhedkar AA. Design of experiment avenue for development and validation of RP-HPLC-PDA method for determination of apremilast in bulk and in in-house tablet formulation. Journal of Analytical Science and Technology. 2019 Dec 1;10(1):10.
Landge SB, Dahale SB, Jadhav SA, Solanki PV, Bembalkar SR, Mathad VT. Development and validation of stability indicating rapid RP-LC method for determination of process and degradation related impurities of Apremilast, an anti-inflammatory drug. American Journal of Analytical Chemistry. 2017 Jun 12;8(6):380-94.
Chaudhari SR, Shirkhedkar AA. Application of Box-Behnken Design for Validation of High Performance Thin-Layer Chromatography/Densitometry Method for Robustness Determination of Apremilast in Bulk and inhouse Tablets. Pharmaceutical Methods. 2018 Jan 1;9(1).
Bhole RP, Naksakhare SR, Bonde CG. A Stability Indicating HPTLC Method for Apremilast and Identification of degradation products using MS/MS. Journal of Pharmaceutical Sciences and Research. 2019 May 1;11(5):1861-9.
Chakravarthy AV, Sailaja BB, Kumar PA. Method development and validation of ultraviolet-visible spectroscopic method for the estimation of assay of sugammadex sodium, Apremilast, riociguat, and vorapaxar sulfate drugs in active pharmaceutical ingredient form. Asian J Pharm Clin Res. 2017;10(2):241-50.
Intwala JK, Doshi DB. DEVELOPMENT AND VALIDATION OF SOPHISTICATED ANALYTICAL METHOD FOR THE ESTIMATION OF APREMILAST. Pharma Science Monitor. 2017 Apr 1;8(2).
Hemaraj R. Patil, Dr. S. T. Patil, V. H. Jain And Dr. S. P. Pawar. Devlopment And Validation of Uv-Spectrophotometric and Hplc Method for Apremilast In Bulk and Tablet Dosage Form. Ejpmr, 2019,6(8), 233-239
Lonkar NA, Dole MN, Sawant SD. Development and validation of UV spectrophotometric method for the estimation of apremilast in bulk form by absorbance maxima method. World J Pharm Pharm Sci. 2017 Apr 22; 6(7):758-66.
Iqbal M, Ezzeldin E, Al-Rashood ST, Imam F, Al-Rashood KA. Determination of apremilast in rat plasma by UPLC–MS/MS in ESI-negative mode to avoid adduct ions formation. Bioanalysis. 2016 Jul;8(14):1499-508.
Chen LG, Wang Z, Wang S, Li T, Pan Y, Lai X. Determination of apremilast in rat plasma by UPLC–MS-MS and its application to a pharmacokinetic study. Journal of chromatographic science. 2016 Sep 1;54(8):1336-40.
Lonkar, N., Sawant, S. And Dole, M. Development and Validation of Stability Indicating RP-HPLC Method for The Estimation of Apremilast By Forced Degradation Studies. W. J Pharm Pharm Sci. 2017a, 6, Pp.1493-502.
Rajan V Rele and Patil SP. Reversed Phase High Performance Liquid Chromatography Method for Determination of Assay and Forced Degradation Study Of Apremilast From Active Pharmaceutical Dosage Form. Journal of Chemical and Pharmaceutical Research, 2018, 10(7): 139-144
Ravisankar P, Sulthana MS, Babu PS. Development and validation of stability-indicating UV spectrophotometric method for determination of Apremilast in bulk and pharmaceutical dosage form. Ind J Res Pharm Biotechnol. 2017; 5:47.
Kulsum S, Sagar GV, Butul A, Fatima S, Uddin S. Method development and validation of forced degradation studies of apremilast by using UV spectrophotometric method. World Journal of Pharmacy and Pharmaceutical Sciences. 2016;5(6):1595-601.
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