A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF AVAPRITINIB IN BULK AND TABLET DOSAGE FORM

SUVASISH MISHRA; KOUSHIK SARKER; AVIJIT GHOSH; ABHIJIT SAHA; SUBRATA SEN

doi:10.22159/ijap.2022v14i2.43432

Authors

SUVASISH MISHRA A.P.C. Ray Memorial Cancer Chemotherapeutic Research unit, College of Pharmaceutical Sciences, Berhampur, Odisha https://orcid.org/0000-0001-5738-6299
KOUSHIK SARKER A.P.C. Ray Memorial Cancer Chemotherapeutic Research unit, College of Pharmaceutical Sciences, Berhampur, Odisha
AVIJIT GHOSH A.P.C. Ray Memorial Cancer Chemotherapeutic Research unit, College of Pharmaceutical Sciences, Berhampur, Odisha
ABHIJIT SAHA A.P.C. Ray Memorial Cancer Chemotherapeutic Research unit, College of Pharmaceutical Sciences, Berhampur, Odisha
SUBRATA SEN A.P.C. Ray Memorial Cancer Chemotherapeutic Research unit, College of Pharmaceutical Sciences, Berhampur, Odisha

DOI:

https://doi.org/10.22159/ijap.2022v14i2.43432

Keywords:

Avapritinib, RP-HPLC, Method development, Forced degradation

Abstract

Objective: The present investigation aims to develop a simple, cost effective, and reliable stability-indicating RP-HPLC assay method for analysis of avapritinib in bulk and the tablet dosage form.

Methods: The method was developed using Acetonitrile and Methanol in a ratio of 70:30 (v/v) as the mobile phase, flowing at a rate of 1 ml/min, in an isocratic mode. A reverse phase column (Symmetry C18 column, 250 mm x 4.6 mm, 5 µm) was used as the stationary phase. The detection of the compound was made using a UV detector set at 245 nm. The validation and force degradation studies of the method were done following the International Conference on Harmonization (ICH) guidelines.

Results: The method was validated using the prescribed parameters like system suitability, LOD, LOQ, accuracy, precision, robustness, specificity etc. The relative standard deviation (% RSD) of the peak area observed in each case was found within the accepted range (< 2%). The tailing factor and the plate count were found to be less than 2 and more than 2000 respectively in each observation. The coefficient of correlation (r²) value in the linearity study was found to be 0.9997. The drug was found to be quantified accurately in presence of its degraded products.

Conclusion: The developed simple and economic method is a suitable option for the qualitative and quantitative study of avapritinib in bulk and tablets even in presence of its degraded products which may arise because of oxidation, hydrolysis, thermal and photolytic decomposition.

Downloads

Download data is not yet available.

References

Dhillon S. Avapritinib: First Approval. Drugs. 2020 Mar;80(4):433-39.

Bose P, Verstovsek S. Avapritinib for Systemic Mastocytosis. Expert Review of Hematology. 2021 Aug 06;14(8):687-96.

Pardanani A. Systemic mastocytosis in adults: 2017 update on diagnosis, risk stratification and management. Am J Hematol. 2016 Nov;91(11):1146-59.

Lübke J, Naumann N, Kluger S, Schwaab J, Metzgeroth G, Evans E, Gardino AK, Lengauer C, Hofmann WK, Fabarius A, Cross NCP, Reiter A, Jawhar M. Inhibitory effects of midostaurin and avapritinib on myeloid progenitors derived from patients with KIT D816V positive advanced systemic mastocytosis. Leukemia. 2019 May;33(5):1195-1205.

Valent P, Akin C, Sperr WR, Escribano L, Arock M, Horny HP, Bennett JM, Metcalfe DD. Aggressive systemic mastocytosis and related mast cell disorders: current treatment options and proposed response criteria. Leuk Res. 2003 Jul;27(7):635-41.

Kufe DW, Pollock RE, Weichselbaum RR, Gansleret TS, Holland JS, Frei E. editors. Holland-Frei Cancer Medicine. 6th edition. Hamilton (ON):BC Decker;2003.

Lennert K, Parwaresch MR. Mast cells and mast cell neoplasia: a review. Histopathology. 1979 Sep;3(5):349-65.

Kumari GK, Rambabu K. Bio-analytical Method Development and Validation for Avapritinib in Rat Plasma by LC-MS/MS. J. Pharm. Sci. & Res. 2021;13(3):134-37.

Xu X, Luo S, Yang Q, Wang Y, Li W, Lin G, Xu R. Development and validation of the quantitative determination of avapritinib in rat plasma by a bioanalytical method of UPLC-MS/MS. Arabian Journal of Chemistry. 2021 June;14(6):103152.

Singh TG, Vadlakonda JB, Gupta VRM. Analytical method development and validation of avapritinib by RP-HPLC method. World journal of pharmacy and pharmaceutical sciences. 2020 Oct; 9(10):1834-40.

Laha TK, Mishra S, Sen S. RP-HPLC Method for the Determination of Tamsulosin in Bulk and Pharmaceutical Dosage Forms. Asian Journal of Chemistry. 2011 Jan;23(1):11-14.

Tirumalasetty N, Ramchandran D. New stability indicating method development and validation of capecitabine and docetaxel in bulk and pharmaceutical dosage form by using RP-HPLC. Int J App Pharm, 2021 Sept;13(5):177-82.

Validation of Analytical Procedures: Methodology (Q2R1), International conference on Harmonization, Food and Drug Administration, USA, November (2005).

Yarlagadda SR, Mannam SR, Jampani BP. Stability indicating and cost-effective analytical method development and validation of sotorasib by using RP-HPLC. Int J App Pharm. 2021 Sept 07;13(5):154-59.

Reddy CS, Rao BT. Development and validation of a stability-indicating related substances of trandolapril by RP-HPLC and its degradation. Int J App Pharm. 2021 Sept 07;13(5):115-21.

Sangeetha M, Tirumala, Nagamallika. Stability indicating RP-LC assay method for carisoprodol. International Journal of Current Pharmaceutical Research. 2017 Nov 14;9(6):79-85.

Bodempudi SB, Rupakula RCB, Reddy KS. Development and validation of RP-chiral HPLC method for quantification of (s)-isomer in tenofovir disoproxil fumarate. International Journal of Current Pharmaceutical Research, 2017 Nov 14;9(6):31-36.

Deshpande S, Farooqui M, Ganap G, Khadke V, Kayande DD. Development and validation of a gradient HPLC method for quantification of edetate disodium in lyophilized injectable drug product. International Journal of Current Pharmaceutical Research, 2019 May 15;11(3):38-41.

International Conference on Harmonization ICH-Q2 (R1), Guideline on Validation of Analytical Procedure: Text and Methodology (2005).

US Department of Health and Human Services Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Centre for Biologics Evaluation and Research (CBER), Guidance for Industry: ICHE6 Good Clinical Practice (1996).

Theeruvidhi VLNBG, Battula VR, Bonige KB. RP-HPLC (stability-indicating) based assay method for the simultaneous estimation of doravirine, tenofovir disoproxil fumarate and lamivudine. Int J Appl Pharm. 2021 Jan 07;13(1):153-59.

Murali Krishnam Raju P, Venkata Narayana B, Shyamala P, Srinivasu K, HSN Raju D. A validated RP-HPLC method for impurity profiling of Sodium nitroprusside in an injection dosage form. Int J Appl Pharm. 2021 Jan 07;13(1):160-69.

Sri Girija K, Bikshal Babu K, Venkateswara Rao A. A new high-performance liquid chromatography method for the separation and simultaneous quantification of eptifibatide and its impurities in pharmaceutical injection formulation. Int J Appl Pharm. 2021 Mar 07;13(2):165-72.

Shalini K, Ilango K. Development, evaluation and RP-HPLC method for simultaneous estimation of quercetin, ellagic acid and kaempferol in a polyherbal formulation. Int J Appl Pharm. 2021;13(3):183-92.

Rode DM, Rao NN. A review on development and validation of stability indicating HPLC methods for analysis of acidic drugs. International Journal of Current Pharmaceutical Research, 2019 July 15;11(4):22-33.

Choppella V, Raghu Babu K, Badipati S, Gonthina H, Chukka VK. Stability indicating method development and validation for simultaneous quantification of sorafenib and regorafenib drug subtances by using RP-UPLC. International Journal of Current Pharmaceutical Research, 2020 Jan 15;12(1):56-62.

Srujani CH, Annapurna P, Nataraj KS, Krishna MPA. Analytical quality by design approach in RP-HPLC method development and validation for the estimation of duvelisib. Asian Journal of Pharmaceutical and Clinical Research, 2021 Feb 07;14(2):99-108.

Singha SS, Sreenivas RT. Development and validation of an RP-HPLC method for the determination of ulipristal acetate in bulk and pharmaceutical dosage form. Asian Journal of Pharmaceutical and Clinical Research, 2021 Apr 07;14(4):83-89.

Koga AY, Carletto B, Lipinski LC, Klein T, Farago PV. Development and validation of an High-performance liquid chromatography method for the determination of 17-β estradiol in polymeric nanoparticles. Asian Journal of Pharmaceutical and Clinical Research, 2021 May 07;14(5):112-116.

Satapathy B, Bangari C. A new robust analytical method development and validation for simultaneous estimation of ribociclib and letrozole in solid dosage form (tablet). Asian Journal of Pharmaceutical and Clinical Research, 2021 Nov 07;14(11):129-134.

Bakshi M, Singh S. Development of validated stability-indicating assay methods-critical review. J. Pharm. Biomed. Anal. 2002 Jun 15;28(6):1011-40.

International Conference on the Harmonisation, ICH Harmonized Tripartite Guideline. Stability Testing of New Drug Substances and Products Q1A (R2), November (2003).

Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs—A review. J. Pharm. Anal. 2014 Sept 17;4(3):159-65.

Murugesan A, Annapurna MM. Validated and quantified stability indicating stress degradation study of oral anti-diabetic agent canagliflozin by RP-HPLC method. Int J App Pharm. 2021 Sept;13(5):358-63.

Suchitra D, Satyanarayana B. Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of ethinyl estradiol and gestodene in bulk and pharmaceutical dosage forms. International Journal of Pharmacy and Pharmaceutical Sciences, 2021 July 01;13(7):49-58.