Stability indicating analytical method development and validation of eltrombopag olamine in tablet dosage form by RP-UPLC

Yıl 2020, Cilt: 7 Sayı: 3, 845 - 850, 30.10.2020

Ajay I Patel Shweta Gosaı , Kajal Jadav Amit J. Vyas Ashok B Patel Nilesh K Patel

https://doi.org/10.18596/jotcsa.724484

Cited By: 6

Öz

A simple, precise and accurate stability indicating isocratic Reverse Phase Ultra-Performance Liquid Chromatographic (RP-UPLC) method was developed for quantitative determination of Eltrombopag olamine in the presence of degradant products. The method was developed using Acquity UPLC BEH C18 (50 × 2.1 mm, 1.7 μm) column with mobile phase containing a mixture of water (pH 3 with 30 % formic acid) and acetonitrile in ratio 30:70. The eluted compound was monitored at 244 nm and run time was within 2 min. Eltrombopag olamine was subjected to the stress condition of oxidative, acid, base, thermal and photolytic degradation. The drug was found to degrade significantly in acid, base and oxidative stress condition and stable in thermal and photolytic degradation condition. The degradation products were well resolved from main peak, providing stability indicating power of the method. The developed method was validated as per ICH Q2(R1) guideline with Linearity range was between 25-75 μg/ml, % Recovery range was found as 99.8-101.9 and Precision was found as RSD less than 2.

Anahtar Kelimeler

Eltrombopag olamine, ultra performace high liquid chromatography, stability indicating, force degradtion, validation

Kaynakça

• 1. Zhang Z and Kolesar JM. Eltrombopag: An Thrombopoietin Receptor Agonist for the Treatment of idiopathic Thrombocytopenic Purpura. Clinical Therapeutics. 2011; 33: 1560-1576.
• 2. Gonzalez JR and Bastida JM. Eltrombopag in immune thrombocytopenia: efficacy review and update on drug safety. Therapeutic Advance in Drug Safety. 2018; 9: 263-285.
• 3. ICH – Harmonized Tripartite Guideline. Stability testing of New drug substance and products Q1A (R2). International Conference on Harmonization. IFPMA, Geneva, Switzerland, 2003.
• 4. Singh S and Bakshi M. Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs. Pharmaceutical Technology. 2000; 1-14.
• 5. Blessy M, Patel RD, Prajapati PN and Agrawal YK. Development of forced degradation and stability indicating studies of drugs – A review. J. Phar. Anal. 2013; 4: 159- 165.
• 6. Pal N, Pravalika P, Bhavani DS, Geetha R, Afreen A and Rao AS. New method development and validation for the determination of Eltrombopag in bulk and tablet dosage form by HPLC. World journal of Pharmacy and Pharmaceutical science. 2018; 7: 1176-1184.
• 7. Madasu RK, Isreal S and Rao NV. Development and validation for detection of DIC and IHC in Eltrombopag olamine tablet by RP-HPLC method. World journal of Pharmacy and Pharmaceutical science. 2018; 7: 744-762.
• 8. Sindhuriya M, Chaudhari GV, Shah P and Khoja SS. Development and validation of Stability indicating RP-HPLC method for estimation of Eltrombopag olamine in pharmaceutical dosage form. European journal of Biomedical and Pharmaceutical science. 2018; 5: 454-460.
• 9. Manoharan G. Development and validation of Stability indicating RP-HPLC method for estimation of the Eltrombopag in bulk and tablet formulation. Asian journal of Chemical science. 2018; 4(1): 1-9.
• 10. Mohan TSSJ, Khagga M and Jogia HA. Stability indicating UHPLC method development and validation for estimation of Eltrombopag and related impurities in tablet dosage form. Oriental journal of chemistry. 2018; 34: 1098-1104.
• 11. Marakatham S, Vallikumari RV and Meruva SK. Spectrophotometric method for determination of Eltrombopag in bulk and pharmaceutical formulation. International journal of Research in Pharmacy and Biosciences. 2017; 4: 13-16.
• 12. Basha DM, Reddy GV, Rani TS, Susithra E and Chekkara R. RP-UPLC-MS assay method for Eltrombopag: application in pharmaceuticals, human plasma and urine samples. Asian J. Chem. 2015; 27: 4615-4619.
• 13. Maddela R, Gajula R, Pilli NR, Siddiraju S, Maddela S and Makula A. Liquid chromatography-tanden mass spectrometric assay for Eltrombopag in 50 μl of human plasma: A pharmacokinetic study. J. Pharm. Biomed. Anal. 2014; 1-23.
• 14. ICH – Harmonized Tripartite Guideline. Validation of analytical procedures: text and methodology Q2 (R1). International Conference on Harmonization. IFPMA, Geneva, Switzerland, 2005.