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

Authors

  • T. Malavika Jawaharlal Nehru technological University, Hyderabad
  • N. Kartheek Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • A. Ashok Kumar Jawaharlal Nehru technological University, Hyderabad (JNTUH)

Keywords:

Nil, 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 developed method uses a reverse phase C18 column, INERTSIL ODS 3V column (250X4.6 mm; 5μ), mobile phase consisting of Potassium dihydrogen orthophosphate buffer (adjusted using 30% v/v of ortho phosphoric acid pH 3.5):methanol: acetonitrile in the proportion of 20:40:40 v/v. The mobile phase was set at a flow rate of 1.2 ml/min and the volume injected was 20μl for every injection. The detection wavelength was set at 220 nm.

Results: The developed method resulted in Indinavir sulphate eluting at 3.75 min. Indinavir sulphate exhibited linearity in the range 60-140μg/ml. The precision is exemplified by relative standard deviation of 0.709%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) and limit of quantitation (LOQ) was found to be 104ng/ml and 315ng/ml respectively.

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

 

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Author Biographies

T. Malavika, Jawaharlal Nehru technological University, Hyderabad

Department of Pharmaceutical Analysis and Quality assurance, M.Pharmacy student

N. Kartheek, Jawaharlal Nehru technological University, Hyderabad (JNTUH)

Department of Pharmaceutical Analysis and Quality assurance, M.Pharmacy student

A. Ashok Kumar, Jawaharlal Nehru technological University, Hyderabad (JNTUH)

Professor and Head of the 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. 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. Antimicrob Agents Chemother 1998;42(2):332-8.

Patrick AK, Potts KE. Protease Inhibitors as antiviral agents. 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.

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 Braz Chem Soc 2006;17(2);251-6.

Johnson BD, Howard A, Varsolona R, McCauley J, Ellison DK.

Analytical profiles of drug substances and excipients indinavir. Anal Profiles Drug Subs 1999;26:319-57.

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

Rajitha K, Lakshmi prasanna N, Naveen R, Ranjith CH, Ashok kumar A. A rapid RP-HPLC method development and validation for the quantitative estimation of Indinavir in capsules. Int J Pharm Pharm Sci 2014;6(8):453-6.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of Analytical Procedures: Text and Methodology ICH Q2 (R1); 2005.

Published

01-02-2015

How to Cite

Malavika, T., N. Kartheek, and A. A. Kumar. “METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF INDINAVIR IN CAPSULES BY RP-HPLC”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 2, Feb. 2015, pp. 343-6, https://journals.innovareacademics.in/index.php/ijpps/article/view/3608.

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