scholarly journals Development and Validation of First Order Derivative Method for Tenofovir alafenamide in Bulk using UV Visible Spectroscopy

2018 ◽  
Vol 11 (8) ◽  
pp. 267-273
Author(s):  
Dudhe P.B ◽  
Choudhary E. D.
Keyword(s):  
Order Derivative ◽  
Visible Spectroscopy ◽  
First Order ◽  
Derivative Method ◽  
Uv Visible ◽  
Tenofovir Alafenamide ◽  
Development And Validation

scholarly journals DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF GEMCITABINE HYDROCHLORIDE IN BULK AND POLYMERIC NANOPARTICLES

2017 ◽  
Vol 9 (5) ◽  
pp. 60 ◽  
Author(s):  
Taranjit Kaur ◽  
Sukhjinder Kaur ◽  
Parminderjit Kaur
Keyword(s):  
Polymeric Nanoparticles ◽  
Visible Spectroscopy ◽  
International Conference ◽  
Spectrophotometric Methods ◽  
Gemcitabine Hydrochloride ◽  
Double Beam ◽  
Uv Visible ◽  
Formulation Analysis ◽  
Development And Validation

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. 267.2 nm, λmax of the drug in distilled water, phosphate buffer pH 6.8 and 7.4. The method obeyed Beer Lambert’s law in the concentration range of 5-30 µg/ml andR2-value was found to be 0.999. Moreover, the % drug recovered from polymeric nanoparticles was found to be 97.97%.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.

scholarly journals AN EXPERIMENTAL DESIGN APPROACH FOR OPTIMIZATION OF MODIFIED COLORIMETRIC FIRST-ORDER DERIVATIVE METHOD FOR ESTIMATION OF SERRALYSIN IN BULK AND PHARMACEUTICAL FORMULATION

2018 ◽  
Vol 11 (9) ◽  
pp. 293
Author(s):  
Kulkarni Manasi B ◽  
Joshi Anagha M
Keyword(s):  
Experimental Design ◽  
Response Surface ◽  
Pharmaceutical Formulation ◽  
Design Approach ◽  
Order Derivative ◽  
Contour Plot ◽  
Colored Complex ◽  
First Order ◽  
Derivative Method ◽  
Phenol Reagent

Objective: The aim of the present work is to use experimental design to screen and optimize experimental variables for developing a colorimetric first-order derivative method for determining content of serralysin (SER) using biuret and Folin–Ciocalteu phenol reagent for stable color development. The method is based on the reaction of peptide bond in the protein with Biuret reagent in alkaline medium and further reaction of remaining tryptophan and tyrosine residues with Folin–Ciocalteu Phenol reagent to form a stable blue-colored complex (first-order derivative λmax 620 nm).Materials and Methods: A two-level full factorial design was utilized to screen the effect of Volume of NaOH (A), volume of biuret reagent (B), volume of Folin–Ciocalteu phenol reagent (C), and concentration of NaOH (D) on the formation of blue-colored SER - reagent complex (response - absorbance). A box Behnken experimental design with response surface methodology was then utilized to evaluate the main interaction and quadratic effects of these factors on the selected response.Results: With the help of a response surface plot and contour plot, the optimum values of the selected factors were determined and used for further experiments. These values were volume of NaOH (A) of 1.0 mL, volume of biuret reagent (B) of 0.25 mL, and volume of Folin–Ciocalteu phenol reagent (C) of 10 μL. The proposed method was validated according to the ICH Q2(R1) method validation guidelines. The developed colorimetric first-order derivative method was found to be simple, accurate, rapid, sensitive, precise, and economic. Further optimization of the method with experimental design approach makes it convenient for use in laboratory.Conclusion: The results of present study have clearly shown that an experimental design approach may be effectively applied to the optimization of a modified visible spectrophotometric method for estimation of SER in bulk and in pharmaceutical formulation with the least number of experimental runs possible. The method can be employed successfully for the estimation of SER in both bulk and tablet dosage form. 

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