Volume : 11, Issue : 01, January – 2024

Title:

A REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF DECITABINE BY DIFFERENT ANALYTICAL TECHNIQUES

Authors :

Santhosh Illendula*, Mohammad Bushra, Budida Manasa, Chinthapally Ganesh, Dr. CH . V Suresh , Dr. K N Venkateswara Rao

Abstract :

Pharmaceutical analysis is a broader term which can be defined in many ways. It is the series of processes that are used for identification, determination, separation, purification, and structure elucidation of the given compound used in the formulation of pharmaceutical products. Recent development in analytical methods has been resulted from the advancement of analytical instruments. The improvement of the analytical method development and analytical instruments like UV, HPLC, LC-MS, GC are required for reduced the time of analysis, increased precision and accuracy and reduced costs of analysis. Decitabine (i.e., 5-aza-2′-deoxycytidine) acts as a nucleic acid synthesis inhibitor.It is a medication for the treatment of myelodysplastic syndromes, a class of conditions where certain blood cells are dysfunctional, and for acute myeloid leukemia (AML). Chemically, it is a cytidine analog.
Key words: Analytical method development, validation, Decitabine, UV, HPLC, LC-MS, GC

Cite This Article:

Please cite this article in press Santhosh Illendula et al., A Review On Method Development And Validation Of Decitabine By Different Analytical Techniques, Indo Am. J. P. Sci, 2024; 11 (01).

Number of Downloads : 10

References:

1. G.H. Jeffery, J. Bassett, J. Mendham and R.C. Denney, Vogel’s Text Book of Qualitative Analysis, 5th Edn. Longman Scientific & Technical Publication, (1988), 708.
2. P.D. Sethi, Quantitative Analysis of Pharmaceutical Formulations, 3rd Edn. CBS Publishers and Distributors, (1997), 51.
3. B.K. Sharma, Instrumental Methods of Chemical Analysis, Goel Publishers, (1999), 13. Rasayan Journal of chemistry Vol. 5 | No.1 | 90-105 | January-March | 2012ISSN: 0974-1496 | CODEN: RJCABP.
4. H.H.Williard, L. L .Merit, F. A .Dean and F. A .Settle, Instrumental methods of analysis, 7th edition, C .B .S .Publishers, New Delhi,( 2002).
5. International Conference on Harmonization, “Q2A: Text on Validation of Analytical Procedures,” Federal Register 60(40), 11260–11262 (1995).
6. International Conference on Harmonization, “Q2B: Validation of Analytical Procedures: Methodology; Availability,” Federal Register 62(96), 27463–27467 (1997).
7. https://go.drugbank.com/drugs/DB01262
8. https://en.wikipedia.org/wiki/Decitabine
9. Santhosh Illendula, Nabeeda Raheman, Jhansi Kandhala, Dr. K N V Rao: A Review on Novel method development & validation of decitabine by different analytical techniques, World journal of pharmacy and pharmaceutical sciences. 2021; 10(06): 2096-2116
10. Santhosh Illendula, Naveen kumar Singhal: A Review: Novel analytical method development & validation for the determination of selected anti cancer & anti viral drugs, World journal of pharmacy and pharmaceutical sciences. 2022;11(07):533-566
11. Ankit Awasthi, Dheeraj HM, Muddukrishna Badamane Sathyanarayana. Novel Validated Uv Spectroscopic Method for Routine Analysis of Decitabine Drug Substance, the analysis of Decitabine which is antineoplastic drug. 2020; 54(3s):s667-s670.
12. Byasabhusan Das 1,Niranjan Panda , Kanhu Charan pandu , Development of a New Rapid, Efficient and Reproducible Reverse Phase – HPLC Method for the Analysis of Decitabine in Bulk and Tablet Dosage Form, 2017; 5 (4): 1800-04.
13. Suresh Reddy. Yelampalli, J. V. Shanmukha Kumar1, Useni Reddy Mallu. Development and Validation of HPLC Method for determination of Decitabine impurity profile in Decitabine for Injection 50mg/vial, novel, protected economic, delicate and cost-effective UV-Spectrophotometric technique for the analysis of Decitabine which is antineoplastic drug. 12(4): April 2019:1885-1894.
14. Glory hepsiba1, Dr. B. B. Teja , K. Ashok kumar1 , Y. Ravindra reddy1 , Uttham kumar panigrahi1 ,T Karunakar Reddy1 karuna Reddy. Stability indicating RP-HPLC Method Devlopment and Validation of Decitabine Drug in Formulation, Vol. 3, No.1, pp 237-243, Jan-Mar 2011.
15. Yub Raj Neupane, Manish Srivastava, Nafees Ahmad, Kriti Soni, & Kanchan Kohli. The developed method was further applied to observe the degradation of DCB under various stress conditions, Vol 5 No 07 Jul 2014,294-302.
16. Sunil kumar Adupa, K. Satish and J. Ravi. Development and validation method for decitabine injection by Rphplc, 2014; Vol. 5(8): 3425-29.
17. .CH.V.Suresh, M. Sri Raaga, Santhosh Illendula ;Development of stability indicating RP-HPLC method and validation for the estimation of cabotegravir and Dipivefrine in pure form and marketed pharmaceutical dosage form , YMER 22(02) Feb 2023, 703-725.
18. Santhosh Illendula, S Jyothi & K rajeswar Dutt ; Development and validation of an RP HPLC method for the determination of riociguat in pharmaceutical dosage form, International Journal of research 10(2) Feb 2021 ,344-357.
19. Santhosh Illendula, M. Sanjana, K Rajeswar Dutt ; A validated stability indicating RP_HPLC method development for the estimation of pomalidomide in bulk & pharmaceutical dosage form , International Journal of Pharmacy Biological Sciences 09(01) 2019, 63-72.
20. .Santhosh Illendula, A. Navyasree, CH. Ganesh, K.Sneha & KNV Rao ; Method development & validation of Axitinib in bulk & pharmaceutical dosage form by UV spectroscopic method, Indo American Journal of Pharmaceutical Sciences 06(03) 2019, 6221-6227.