- CODEN : IAJPBB
- issn 2349-7750
TITLE:
VALIDATED UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF GEMCITABINE IN BULK AND DOSAGE FORM
AUTHORS:
Dr. K. Padmalatha, Vijaya Durga. D, Sk. Salma, N. Naga Lakshmi, Ch. Janaki, U. Sony, M. Shireen, K.V. S. S. Sahithi
ABSTRACT:
Objective: The objective of the present work was to develop and validate a novel, specific, precise and reliable method for estimation of gemcitabine hydrochloride in bulk and polymeric nanoparticles using UV-visible spectroscopy method. Methods: The UV-Visible spectrophotometric determination was performed with double beam Systronics UV-visible spectrophotometer; model UV-2201 (India). The proposed methods were validated for various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits, and formulation analysis as per international conference on harmonization (ICH) guidelines. Results: The method was based on measurement of absorbance at wavelength maxima i.e. 260 nm, λmax of the drug in distilled water. The method obeyed Beer Lambert’s law in the concentration range of 5-30 µg/ml and R2-value was found to be 0.999. Moreover, the % drug recovered from formulation was found to be 99.1%. Conclusion: According to results, the currently developed method shows compliance with acceptance criteria with Q2 (R1) and international conference on harmonization (2005) guidelines, because the % RSD was found to be less than 2%. The developed method was simple, accurate and précised. Keywords: Gemcitabine Hydrochloride, UV-Visible Spectrophotometer, Correlation coefficient, λmax
FULL TEXT
Approved Journal
NLM ID:101711216 [Serial]
Included in EuroPub database
ICV 2015 - 61.16
Indexed In
S.J Impact Factor:7.157
cosmos Impact Factor:4.153
ICMJE Recommendations
IP Indexing Impact Factor: 2.76
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