A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF INDINAVIR IN CAPSULES

Authors

  • K. RAJITHA Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad 501511, India.
  • N. LAKSHMI PRASANNA Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad 501511, India.
  • R. NAVEEN Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad 501511, India.
  • C. H. RANJITH Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad 501511, India.
  • A. ASHOK KUMAR Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad 501511, India.

Keywords:

RP-HPLC, Indinavir sulphate, Method development, Validation

Abstract

Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Indinavir sulphate (400mg) in capsules.

Methods: The optimized method uses a reverse phase column, Enable Make C18G (250 X 4.6 mm; 5μ), a mobile phase of triethylammonium phosphate buffer (pH 2.5): acetonitrile in the proportion of 50:50 v/v, flow rate of 1.0 ml/min and a detection wavelength of 220 nm using a UV detector.

Results: The developed method resulted in Indinavir sulphate eluting at 2.7 min. Indinavir sulphate exhibited linearity in the range 50-150μg/ml. The precision is exemplified by relative standard deviation of 1.7%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 4.34ng/ml and 13.15ng/ml respectively.

Conclusion: An accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of Indinavir sulphate in INDIVAN (400mg) capsules as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.

Downloads

Download data is not yet available.

Author Biographies

K. RAJITHA, Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad 501511, India.

Department of Pharmaceutical Analysis and Quality assurance

N. LAKSHMI PRASANNA, Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad 501511, India.

Department of Pharmaceutical Analysis and Quality assurance

R. NAVEEN, Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad 501511, India.

Department of Pharmaceutical Analysis and Quality assurance

C. H. RANJITH, Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad 501511, India.

Department of Pharmaceutical Analysis and Quality assurance

A. ASHOK KUMAR, Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal),Hyderabad 501511, India.

Department of Pharmaceutical Analysis and Quality assurance

References

Vacca JP, Dorsey BD, Schleif WA, Levin RB, McDaniel SL, Darke PL, et al. L-735,524:an orally bioavailable human immunodeficiency virus type 1 protease inhibitor. J Proc Natl Acad Sci USA 1994;91(9):4096-100.

Yeh KC, Deustsch PJ, Haddix H, Hesney M, Hoagland V, Ju WD, et al. Single-Dose Pharmacokinetics of Indinavir and the Effect of Food. J Antimicrob Agents Chemother 1998;42(2):332-8.

Patrick AK, Potts KE. Protease Inhibitors as Antiviral Agents. J Clin Microbiol Rev 1998;

11(4):614-27.

Woolf E, Haddix HM, Matuszewski B. Determination of an in vivo metabolite of a human immunodeficiency virus protease inhibitor in human plasma by high-performance liquid chromatography with tandem mass spectrometry. J Chromatogr A 1997;762(1-2):311-9.

Burger DM, de Graaff M, Wuis EW, Koopmans P, Hekster YA. Determination of Indinavir, an HIV-protease inhibitor, in human plasma by reversed-phase high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 1997;703:235-41.

Dailly E, Thomas L, Kergueris MF, Joillet P, Bourin M. High-performance liquid chromatographic assay to determine the plasma levels of HIV-protease inhibitors (amprenavir, indinavir, nelfinavir, ritonavir and saquinavir) and the non-nucleoside reverse transcriptase inhibitor (nevirapine) after liquid–liquid extraction. J Chromatogr B Biomed Sci Appl 2001;758:129-35.

Foisy ML, Sommadossi JP. Rapid quantification of indinavir in human plasma by high-performance liquid chromatography with ultraviolet detection. J Chromatogr B Biomed Sci Appl 1999;721(2);239-47.

Jayewardene AL, Zhu F, Aweeka FT, Gambertoglio JG. Simple high-performance liquid chromatographic determination of the protease inhibitor Indinavir in human plasma. J Chromatogr B Biomed Sci Appl 1998;707(1-2):203-11.

Jayewardene A, Kearney B, Stone JA, Gambertoglio JG, Aweeka FT. An LC-MS-MS method for the determination of Indinavir, an HIV-1 protease inhibitor, in human plasma. J Pharm Biomed Anal 2001;25(2):309-17.

10.Rose MJ, Merschman SA, Eisenhandler R, Woolf EJ, Yeh KC, Lin L, et al. High-throughput simultaneous determination of the HIV protease inhibitors Indinavir and L-756423 in human plasma using semi-automated 96-well solid phase extraction and LC-MS/MS. J Pharm Biomed Anal 2000;24(2):291-305.

Elisabete AP, Gustavo AM, Marina FMT. Development and validation of a capillary electrophoresis method for the determination of sulphate in Indinavir sulphate raw material. J of the Brazilian Chemical Society 2006;17(2);251-6.

Johnson BD, Howard A, Varsolona R, McCauley J, Ellison DK. J Indinavir Anal Prof Drug Substances 1999;26:319-57.

Rockville MD. United States Pharmacopeial Convention;Pharmacopeial Forum,;1638. 2000;26.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. J Validation of Analytical Procedures Text and Methodology.

Published

31-08-2014

How to Cite

RAJITHA, K., N. L. PRASANNA, R. NAVEEN, C. H. RANJITH, and A. A. KUMAR. “A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF INDINAVIR IN CAPSULES”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 6, no. 8, Aug. 2014, pp. 453-6, https://mail.innovareacademics.in/journals/index.php/ijpps/article/view/1582.

Issue

Section

Original Article(s)

Most read articles by the same author(s)

1 2 3 > >>