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


Rajitha Kothapelly, Lakshmi Prasanna Nalluri, Naveen Kumar Rachawar, Ranjith Ch, Ashok Kumar Akuthota

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 98‐102, 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.

 


Keywords


RP‐HPLC, Indinavir sulphate, Method development, Validation.

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About this article

Title

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

Keywords

RP‐HPLC, Indinavir sulphate, Method development, Validation.

Date

01-09-2014

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 6, Issue 8, 2014 Page: 453-456

Online ISSN

0975-1491

Statistics

130 Views | 29 Downloads

Authors & Affiliations

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

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

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

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

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


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