DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HPLC METHOD FOR ASSAY OF THE OCTAPEPTIDE OCTREOTIDE IN RAW MATERIAL AND PHARMACEUTICAL DOSAGE FORM
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Keywords
Octreotide, RP-HPLC method development, UV detection, Injectable dosage form, Raw material, Mobile Phase
Abstract
The objective of this study was to develop and validate reverse phase high-performance liquid chromatography (RP-HPLC) method for the quantification of octreotide, a somatostatin analogue, in raw material and injectable dosage form by using a UV detector. Octreotide drug molecules are used for carcinoid tumor and acromegaly. RP-HPLC quantification was carried out by using mobile phase comprising acetonitrile, water and tetrabutylammonium hydroxide through an octadecylsilyl (C18) end-capped column (250 mm × 4.6 mm, 5 µm). The flow rate for this assay was 1 ml/min and detection was performed at 210 nm. This method was validated according to the guidelines of the International Council for Harmonization (ICH). The assay was linear in concentration range 0.2-1.8 µg/ml with relative standard deviation less than 2. The performed assay was sensitive with a limit of detection (LOD) 0.025 µg/mL and a limit of quantification (LOQ) 0.084 µg/ml. Similarly, the percentage recovery was 97.02-99.25% that showed the accuracy of the developed method. Results of this study confirmed that method was sensitive, specific, accurate and precise for quantification of octreotide in raw material and injectable dosage forms by using common UV detector.
References
2. Banerjee S, Das RK and Shapiro BH (2013) Growth hormone-independent suppression of growth hormone-dependent female isoforms of cytochrome P450 by the somatostatin analog octreotide. European journal of pharmacology, 715(1-3):256-261.
3. Biemasz NR, Vanden NC and Frolich M (2003) Sandostatin LAR in acromegaly: A 6-week injection intervals suppress GH secretion as effectively as a 4-week intervals. Clinical Endocrinology, 58: 288-295.
4. Carr D (2002) The Handbook of Analysis and Purification of Peptides and Proteins by Reversed Phase HPLC. 3rd ed. Grace Vydac, California, 4-26.
5. Chanson P, Timsit J, and Harris AG (1993). Clinical pharmacokinetics of octreotide. Clinical pharmacokinetics, 25(5):375-391.
6. Claudia von A, Giuseppina R, Maria N, Alessandro O, Fabiana T, Francesco I, Antonella P, Ottavia C, Antonella Di S, Gerardo B, Stefania S and Salvatore T (2020) Effect of Octreotide Long-Acting Release on Tregs and MDSC Cells in Neuroendocrine Tumour Patients: A Pivotal Prospective Study. Cancers, 12: 2442.
7. Colin TM, Yuxin C, Zhe Y, Traian VP, James MK, Janine BM, Brian PT and Robert SH (2007) HPLC Analysis and Purification of Peptides Peptide Characterization and Application Protocols. Methods in Molecular Biology, 386: 3-57
8. Fery F, Tappy L, Schneiter P, Daviere JE and Balasse O (2005) Effect of Somatostatin on Duodenal Glucose Absorption in Man. The J. of Clinical Endocrinology and Metabolism, 90: 4163-4169.
9. Frank N, Hermida P, Sanchez-Londoño A, Singh R, Gradil CM and Uricchio CK (2017) Blood glucose and insulin concentrations after octreotide administration in horses with insulin dysregulation. J. of veterinary Internal Medicine, 31: 1188-1192.
10. Gharia T, Kobarfard F and Mortazavi SA (2013) Development of a Simple RP-HPLC-UV Method for Determination of Azithromycin in Bulk and Pharmaceutical Dosage forms as an Alternative to the USP Method. Iranian J. Pharmaceutical Research, 12: 57-63.
11. Haris B, Saraswathi S and Hussain K (2020) Somatostatin analogues for the treatment of hyperinsulinaemic hypoglycaemia. Therapeutics Advances in Endocrinology and Metabolism, 11: 1-23.
12. International Federation of Pharmaceutical Manufactures and Associations (IFPMA), “Validation of analytical procedures: text and methodology,” in Proceedings of the International Conference on Harmonization (ICH ’96), Methodology Q2 (R1), Geneva, Switzerland, 1996.
13. Jiang Y, Wang J, Wang Y, Du X, Zhang Y, Fawcett JP and Gu J (2007) Determination of long-acting release octreotide, an octapeptide analogue of somatostation, in human plasma by liquid chromatography/tandem mass spectrometry. Rapid Communication in Mass Spectrometry, 21: 3982-3986.
14. Mant CT and Hodges RS (2019) High-performance liquid chromatography of peptides and proteins: separation, analysis, and conformation. CRC pres.
15. McKeage K, Cheer S and Wagstaff AJ (2003) Octreotide long-acting release (LAR): a review of its use in the management of acromegaly. Drugs, 63: 2473-2499.
16. Park EJ, Lee KC, and Na DH (2009) Separation of positional isomers of mono-poly (ethylene glycol)-modified octreotides by reversed-phase high-performance liquid chromatography. J. of Chromatography, 1216: 7793-7797.
17. Singh V, Brenel MD, Zacharias S, Mergler S, Jahr H, Wiedemnan B, Bretzel RG, Plockinger U and Strowski MZ (2007) Charecterization of soamtostatin receptor subtype-specific regulation of insulin and glucagon secretion: An in vitro study on isolated human pancreas. The J. of Clinical Endocrinology and Metabolism, 92: 673-680.
18. Tamvakopoulos C (2007) Mass spectrometry for the quantification of bioactive peptides in biological fluids. Mass Spectrometry Reviews, 26: 389-402.
19. Vance ML and Harris AG (1991) Long-term treatment of 189 acromegalic patients with the somatostatin analog octreotide: results of the International Multicenter Acromegaly Study Group. Archives of Intenal Medicine, 151: 1573-1578.
20. Yau H, Kinaan M, Quinn SL and Moraitis AG (2017) Octreotide long-acting repeatable in the treatment of neuroendocrine tumors: patient selection and perspectives. Biologics, 11: 115.
21. Zhang HY, Xu WQ, Wang YW, Omari-Siaw E, Wang Y, Zheng YY, Cao X, Tong SS, Yu JN and Xu XM (2006) Tumor targeted delivery of octreotide-periplogenin conjugate: synthesis, in vitro and in vivo evaluation. International J. of Pharmacology, 502:98-106.
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Muhammad Shahbaz Yasin
Department of Pharmacy, University College of Pharmacy, University of the Punjab, Lahore 54590, Pakistan
Khalid Hussain
Department of Pharmacy, University College of Pharmacy, University of the Punjab, Lahore 54590, Pakistan
Kashif-ur-Rehman Khan
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, The Islamia University of Bahawalpur, Bahawalpur 63100, Pakistan
Kiran Waris
College of Nursing, Tahseen Ahmad Cheema Institute, Bahawalpur 63100, Punjab, Pakistan.
Muhammad Kamran
College of Nursing, Tahseen Ahmad Cheema Institute, Bahawalpur 63100, Punjab, Pakistan.
Rizwana Dilshad
Swedish College of Pharmacy and Allied Health Sciences Rahim Yar Khan 64200, Punjab, Pakistan
Hafiz Muhammad Usman Abid
Department of Pharmaceutics, Faculty of Pharmacy, Bahaud-Din-Zakariya University, Multan 60700, Pakistan
Iqra Sohail
College of Nursing, Tahseen Ahmad Cheema Institute, Bahawalpur 63100, Punjab, Pakistan.
Sultan Ahmad
Sheikh Zaid Medical College and Hospital, Rahim Yar Khan 64200, Punjab, Pakistan.
Rihana Dilshad
Sheikh Zaid Medical College and Hospital, Rahim Yar Khan 64200, Punjab, Pakistan.
Bilal Ahmad Ghalloo
Department of Medicinal Chemistry, College of Pharmacy, University of Minnesota, Minneapolis, MN 55454, USA