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.

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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

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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://journals.innovareacademics.in/index.php/ijpps/article/view/1582.

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