Author(s): Krishna Kishore Adireddy, Srinivasa Rao Baratam, Nagarjuna Hari Pratap S.

Email(s): adireddi.kk@gmail.com

DOI: 10.52711/0974-360X.2021.00963   

Address: Krishna Kishore Adireddy*, Srinivasa Rao Baratam, Nagarjuna Hari Pratap S.
Department of Pharmaceutical Analysis, St. Ann's College of Pharmacy, Vizianagaram, Andhra Pradesh-535003, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 10,     Year - 2021


ABSTRACT:
A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Etelcalcetide in bulk and parentral dosage form. Quantification of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 µ) as stationary phase with mobile phase consisting of acetonitrile: methanol :water in the ratio of 25: 45 :30 v/v. The method showed a good linear response in the concentration range of 3.75-22.5 µg/ml with correlation coefficient of 0.9999. The flow rate was maintained at 1.0 ml/min and effluents were monitored at 238 nm. The retention time of etelcalcetide was 6.201 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of etelcalcetide in bulk and parentral dosage form.


Cite this article:
Krishna Kishore Adireddy, Srinivasa Rao Baratam, Nagarjuna Hari Pratap S. RP-HPLC Method for Quantification of Etelcalcetide in Bulk and Parentral Dosage Form. Research Journal of Pharmacy and Technology 2021; 14(10):5521-6. doi: 10.52711/0974-360X.2021.00963

Cite(Electronic):
Krishna Kishore Adireddy, Srinivasa Rao Baratam, Nagarjuna Hari Pratap S. RP-HPLC Method for Quantification of Etelcalcetide in Bulk and Parentral Dosage Form. Research Journal of Pharmacy and Technology 2021; 14(10):5521-6. doi: 10.52711/0974-360X.2021.00963   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-10-81


REFERENCES:
1.    Shigematsu T et al. The influence of dialysate Ca concentrations on the therapeutic effects of etelcalcetide with concomitant drugs in patients with secondary hyperparathyroidism. Nephrology (Carlton). 2019.
2.    2: Russo D et al. Etelcalcetide in Patients on Hemodialysis with Severe Secondary Hyperparathyroidism. Multicenter Study in "Real Life". Journal of Clinical Medicine. 2019; 8(7):.
3.    Cunningham J et al. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney International Reports.. 2019; 4(7): 987-9945.
4.    Hain D, Tomlin H and Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrology Nursing Journal. 2019; 46(3): 290-315.
5.    Block GA et al. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019; 14(3):
6.    Xipell M et al. Improved Control of Secondary Hyperparathyroidism in Hemodialysis Patients Switching from Oral Cinacalcet to Intravenous Etelcalcetide, Especially in Nonadherent Patients. Blood Purification. 2019; 48(2): 106-114.
7.    Yoshimura K, Funakoshi Y and Terawaki H. Dramatic Regression of Parathyroid Gland Swelling After Conversion of Calcimimetic Medication From Cinacalcet to Etelcalcetide. Therapeutic Apheresis and Dialysis. 2018; 22(5): 553-554.
8.    Ye J, Deng G and Gao F. Theoretical overview of clinical and pharmacological aspects of the use of etelcalcetide in diabetic patients undergoing hemodialysis. Drug Design Development and Therapy. 2018; 12: 901-909.
9.    Wu B et al. Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis. Journal of Clinical Pharmacology. 2018; 58(6): 717-726.
10.    Shigematsu T. Effects of the Intravenous Calcimimetic Etelcalcetide on Bone Turnover and Serum Fibroblast Growth Factor 23: Post Hoc Analysis of an Open-label Study. Clinical Therapeutics. 2018; 40(12): 2099-2111.
11.    Harada K, Fujioka A, Konno M, Inoue A, Yamada H and Hirota Y. Pharmacology of Parsabiv(®) (etelcalcetide, ONO-5163/AMG 416), a novel allosteric modulator of the calcium-sensing receptor, for secondary hyperparathyroidism in hemodialysis patients. European Journal of Pharmacology. 2019; 842:139-145.
12.    Bhavana V, Hemant TK , Srinivasa YR and Vara Prasad KR. RP-HPLC method for estimation of Solifenacin Succinate in API and Tablet dosage form. Asian Journal of Pharmaceutical Analysis. 2019; 9(3): 118-122.
13.    Mounika PS , Hemant TK , Srinivasa YR and Vara Prasad KR. RP-HPLC Method For Quantification Of Empagliflozin In Pharmaceutical Formulation. Asian Journal of Pharmacy and Technology. 2019; 9(3): 208-211.
14.    Sarvesh S and Vijayakumar TM. RP-HPLC Method Development and Validation of Midazolam: A CYP3A4 Probe Drug. Research Journal of Pharmacy and Technology. 2020; 13(8): 3565-3568.
15.    Vitthal MD, Santosh T and Rahul VP. RP-HPLC Method Validation for Quantitative Analysis of Pemetrexed Disodium Hemipentahydrate. Research Journal of Pharmacy and Technology, 2020; 13(8): 3685-3689.
16.    Deep Shikha Sharma, Sheetu Wadhwa, Sachin Kumar Singh, Arya Ramanunny, Rajan Kumar. Estimation of 5-fluorouracil by high-performance liquid Chromatography Reversed-phase Validated method. Research Journal of Pharmacy and Technology, 2020; 13(9): 4249-4254.
17.    Gupta S. K., Sachan N., Chandra P., Sharma A. K. A Robustustic Eco-Friendly Analytical Method to Quantify Topotecan in Pharmaceuticals by RP-HPLC. Research Journal of Pharmacy and Technology, 2020; 13(9): 4387-4390.
18.    Sarvesh Sabarathinam, T M Vijayakumar. RP-HPLC Method Development and Validation of Midazolam: A CYP3A4 Probe Drug. Research Journal of Pharmacy and Technology, 2020; 13(8): 3565-3568.
19.    Khairi M. S. Fahelelbom, Moawia M. M. Al-Tabakha, Nermin A. M. Eissa, Dana Emad Eddin Obaid, Sadik Sayed. Development and Validation of an RP-HPLC Analytical Method for Determination of Lisinopril in Full and Split Tablets. Research Journal of Pharmacy and Technology, 2020; 13(6): 2647-2652.
20.    Kallol Jana, Beduin Mahanti. Development and Validation of a new improved RP-HPLC Method for estimation of Rosuvastatin calcium in Pharmaceutical dosage form. Research Journal of Pharmacy and Technology, 2020; 13(6): 2886-2892.
21.    Survi Mishra, S. T. Narenderan, B. Babu, Kuntal Mukherjee, S. N. Meyyanathan. Validated Analytical Method for the Estimation of Gemcitabine from its Pharmaceutical Formulation by RP-HPLC. Research Journal of Pharmacy and Technology, 2019; 12(11): 5407-5412.
22.    Sultana S, Vani R and Sunitha M. Analytical Method Development And Validation For The Estimation Of Etelcalcetide In Bulk And Its Dosage Form Using RP-HPLC. Indo American Journal of Pharmaceutical Research. 2017; 7(11): 928-934
23.    ICH - Guidelines Q2A, Validation of Analytical Procedures: Definition and Terminology (CPMP III/5626/94) March (1995). Geneva, Switzerland: ICH. ICH - Guidelines Q2B, Validation of Analytical Procedures: Methodology, (CPMP/ICH/281/95) November (1996). Geneva, Switzerland.

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