A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF INDINAVIR IN CAPSULES
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2014, Vol 6, Issue 8
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.Â
Authors and Affiliations
Rajitha Kothapelly, Lakshmi Prasanna Nalluri, Naveen Kumar Rachawar, Ranjith Ch, Ashok Kumar Akuthota
Keywords
Related Articles
- EP ID EP579750
- DOI -
- Views 80
- Downloads 0
HPTLC METHOD VALIDATION FOR DETECTION AND QUANTIFICATION OF BETULINIC ACID IN ANCISTROCLADUS HEYNEANUS WALL EX. J. GRAHAM
Objective: The present study aims at standardization of Thin Layer Chromatography (TLC) parameters and Validation of High Performance Thin Layer Chromatography (HPTLC) method for detection and quantification of Betulinic...
EFFECT OF LOVASTATIN NANO DRUG DELIVERY SYSTEM ON BONE MINERAL DENSITY (BMD) AND BIOMECHANICAL PROPERTIES OF TIBIA BONES OF WISTAR RATS
Objective: In the present study, transdermal nanoemulsion (NE) gel of lovastatin was investigated for its anti-osteoporosis effect on the long bones of rat i.e. tibia. Methods: Male wistar rats (n=30, weighing 180-200g)...
CD4 T-HELPER CELL COUNT IS AN ALTERNATIVE PROMISING MARKER FOR DOSING CYCLOSPORINE IN KIDNEY TRANSPLANT PATIENT
Objective: The study was aimed to find out the correlation between cyclosporine blood concentrations and (Clusters of Differentiation 4) CD4 T-helper cell count (percentage) in order to use the latter parameter as an alt...
OPTIMIZATION OF NARINGINASE PRODUCTION AND ITS PURIFICATION FROM MICROCOCCUS SP.
Objective: Isolation and purification of naringinase from Mircoccus sp.Methods: The naringinase producing microorganism was isolated from the soil sample by the serial dilution method. The isolate was identified based on...
ANTIFERTILITY ACTIVITY OF β-SITOSTEROL ISOLATED FROM BARLERIA PRIONITIS (L.) ROOTS IN MALE ALBINO RATS.
Objective: Plant–derived male antifertility agents need to address the basic requirements of fertility suppression without affecting libido. This study was undertaken to evaluate the male antifertility potential of the...