A A VALIDATED RP-HPLC METHOD FOR IMPURITY PROFILING OF SODIUM NITROPRUSSIDE IN INJECTION DOSAGE FORM

  • murali krishnam raju potturi School of Chemistry, Andhra University, Visakhapatnam

Abstract

ABSTRACT


 


Objective: The main objective of this research work was to develop and validate a single reverse-phase high-performance liquid chromatography (RP-HPLC) method. This method should be capable of quantifying all known as well as other possible degradation impurities of sodium nitroprusside (SNP) in its injection formulation.


 


Methods: Out of several method development trails during product evaluation, we have observed better separations between known and degradation impurities in Inert sustain C18, (250 x 4.6) mm, 5 µm column at 30 °C temperature. Isocratic elution was carried out by using pH 8.6 phosphate buffer and acetonitrile in the ratio of 65:35 %v/v with a flow rate of 0.8 ml/min. The detection was carried out at 220 nm, with an injection volume of 10 µl.


 


Results: In the proposed method, SNP was eluted at 22.5 min. Nitrite, nitrate, and ferrocyanide were linear from 0.25 to 37 μg/ml, ferricyanide was linear from 1.0 to 37 μg/ml, and SNP was linear from 0.75 to 37 μg/ml. The % RSD for six spiked precision samples found less than 0.5 %. Accuracy was performed for known impurities from LOQ to 150 % for a 0.5 % specification level. The results are found to be in an acceptance range of 90-110 %. The LOQ concentration for nitrite, nitrate, and ferrocyanide was 0.25 μg/ml, for ferricyanide and SNP LOQ was found to be 1.0 μg/ml and 0.75 μg/ml respectively. SNP formulation samples were exposed to different degradation conditions, and the results found specific in the proposed methodology.


 


Conclusion: The proposed RP-HPLC method is specific, precise, accurate, linear, stable, and robust for quantification of known and other possible degradation impurities in SNP injection formulation.

Keywords: RP-HPLC, impurity profiling, injection formulation, sodium nitroprusside, degradation.

References

REFERENCES

1. Sodium Nitroprusside, USP Monographs, official (USP42-NF37), 4045.
2. Sodium Nitroprusside - European Pharmacopoeia 10.3, (01/2016: 0565).
https://www.pharmacopoeia.com/bp-2020/monographs/sodium-nitroprusside
3. NITROPRESS® (sodium nitroprusside injection) product information leaf let, Hospira, Inc., Lake Forest, IL 60045 USA, Document Name: QEN-3406v4.qxp, Reference ID: 3442071.
4. Taylor HT, Styles M, Lamming JA. Sodium nitroprusside as a hypotensive agent in general anaesthesia. br j anuesth 1970; 42: 859-64.
5. Moraca PP, Bitte ME, Hale ED, Wasmuth EC, Poutasse FE. Clinical evaluation of sodium nitroprusside as a hypotensive agent. Anesthesiology 1962; 23: 193-99.
6. Cottrell EJ, Casthely P, Brodie DJ, Patel K, Klein A, Turndorf H. Prevention of Nitroprusside-Induced cyanide toxicity with Hydroxocobalamin. N Engl J Med 1978; 298:809-11.
7. Sodium Nitroprusside, USP Monographs, official (USP42-NF37), 4045.
8. Sodium Nitroprusside - European Pharmacopoeia 10.3, (01/2016: 0565).
https://www.pharmacopoeia.com/bp-2020/monographs/sodium-nitroprusside
9. Gerritse GR. Rapid simultaneous determination of nitrate and nitrite by high-performance liquid chromatography using ultra violet detection. J Chromatogr A 1979; 171:527-29.
10. Chou SS, Chung JC, Hwang DF. A High Performance Liquid Chromatography method for determining Nitrate and Nitrite levels in vegetables. J Food Drug Anal 2003; 11:233-38.
11. Lim HS, Hwang JY, Choi EA, Lee G, Yoon SS, Kim MK. Development and validation of HPLC method for the determination of ferrocyanide ion in food grade salts. Food Chem 2018; 239:1167-74.
12. Frank JM, Johnsonx BJ, Rubin HS. Spectrophotometric determination of Sodium Nitroprusside and Its Photodegradation Products, J Pharm Sci 1976; 65: 45-8.
13. David MB, Marilyn DS, Nancy K and James EC: High-performance liquid chromatographic determination of sodium nitroprusside, J Chromatogr A 1981; 212:339-46.
14. Mahony C, Brown EJ, Stargel WW, Verghese PC, Bjornsson DT, In Vitro Stability of Sodium Nitroprusside Solutions for Intravenous Administration. J Pharm Sci 1984; 73:838-39.
15. Iram F, Iram H, Iqbal A, Husain A. Forced Degradation Studies. J Anal Pharm Res 2016; 3: 1-5.
16. Blessy M, Ruchi DP, Prajesh NP, Agrawal YK. Development of forced degradation and stability indicating studies of drugs-A review. J Pharm Anal 2014; 4:159-65.
17. Reynolds WD, Facchine LK, Mullaney FJ. Available guidance and best practices for conducting forced degradation studies. Pharm Technol 2002; 26: 48-56
18. International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines, Validation of Analytical Procedures, Text, and Methodology, Q2 (R1), Parent Guidelines on Methodology Dated; 1996. p. 6.
19. David MB, Marilyn DS, Nancy K and James EC: High-performance liquid chromatographic determination of sodium nitroprusside. J Chromatogr A 1981; 212:339-46.
20. InertSearch TM for LC, Inertsil ® Applications, Analysis of Potassium ferricyanide and Potassium ferrocyanide, Data No. LB018-0811.
21. Huang HT, Salter G, Kahn LS, Gindt MY. Redox Titration of Ferricyanide to Ferrocyanide with Ascorbic Acid: Illustrating the Nernst Equation and Beer–Lambert Law. J Chem Educ 2007; 84:1461-63.
22. Jahanvee KT, Chirag JP, Patel MM. RP-HPLC method development and validation of macitentan with its known and unknown degradation impurities in its tablet dosage form. Int J App Pharm 2018; 10: 81-9.
23. Adison F, Sanjay Pai PN. A Validated stability indicating rp-hplc method for estimation of tolfenamic acid in presence of its pharmacopoeial impurities. Int J App Pharm 2019; 11: 264-270.
24. International Conference on Harmonization (ICH), Stability testing of new drug substances and products, Q1A (R2); 2003.
Statistics
3 Views | Downloads
How to Cite
potturi, murali krishnam raju. (2020). A A VALIDATED RP-HPLC METHOD FOR IMPURITY PROFILING OF SODIUM NITROPRUSSIDE IN INJECTION DOSAGE FORM. International Journal of Applied Pharmaceutics, 13(1). Retrieved from https://innovareacademics.in/journals/index.php/ijap/article/view/39534
Section
Original Article(s)