Optimization of HPLC Method Using Central Composite Design for the Estimation of Escitalopram and L-Methyl Folate

Author(s):  
D. Sathis Kumar ◽  
D. D. V. S. Roopa Sirisha ◽  
A. Harani ◽  
S. Khanabhi
INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (11) ◽  
pp. 42-49
Author(s):  
C Dhal ◽  
◽  
F. J. Ahmad ◽  
M. Singhal ◽  
A. Kukrety ◽  
...  

An accurate, sensitive, precise, economic and rapid isocratic Reverse Phase High Performance Liquid Chromatography method was developed complying Quality by Design (QbD) trends and validated for determining doxycycline hyclate in bulk drug, tablet and capsule dosage form. The method was optimized using Minitab software with 3 factors (pH of the buffer, flow rate and percentage of buffer in the mobile phase), 2 level (higher limit and lower limit) Central Composite Design (CCD). The results of randomized 20 runs were analyzed for optimum composite desirability to give optimum conditions such as, pH 6.5, flow rate 0.9 mLmin-1 and 30:70 V/V 0.05M potassium dihydrogen orthophosphate buffer adjusted to pH 6.5 using orthophosphoric acid and methanol using C8 column 250 X 4.6 mm X 5.0 μm, injection volume of 10uL, ambient column temperature and ultraviolet detection using photo diode array detector at 360nm as constants. The method was validated as per ICH guidelines and was found linear over a concentration range of 10-100 μg/mL (r2 = 0.999) with the limits of detection and quantification being 2.45 μg/mL and 7.55 μg/mL respectively.


2018 ◽  
Vol 16 (2) ◽  
pp. 137-145
Author(s):  
Chairany Siregar ◽  
Niken K Prabaningdyah ◽  
Syaiful Choiri ◽  
Sugeng Riyanto ◽  
Abdul Rohman

In this study, central composite design (CCD) was used for optimization of high performance liquid chromatographic (HPLC) method for simultaneous analysis of curcumin (CUR) and demethoxycurcumin (DMC) in tablets containing Curcuma extract. Separation of CUR and DMC was performed using X-Bridge C18 column (250 x 4.6 mm i.d; 5 μm). Four factors that were investigated include the concentration of acetic acid (X1), ratio of acetic acid (X2), flow rate of mobile phase (X3) and column temperature (X4). Based on responses obtained (retention time, peak area, resolution and tailing factor), the optimum condition selected was X1 = 3.00%, X2 = 51%, X3 = 1.05 mL/min and X4 = 45oC. This HPLC condition was validated by assessing several validation parameters including system suitability test, selectivity, linearity, precision, accuracy and robustness according to International Conference Harmonization (ICH). All validation parameters meet the acceptance criteria set by ICH. The validated method was successfully used for analysis of CUR and DMC in tablets containing Curcuma extract. CCD was effective means in optimization of HPLC for analysis of CUR and DMC in pharmaceutical formulation.Dhaka Univ. J. Pharm. Sci. 16(2): 137-145, 2017 (December)


Author(s):  
SACHIN A. BABAR ◽  
SUDHAKAR L. PADWAL

Objective: The objective of this research was to develop a simple, very rapid, sensitive, accurate, precise reverse phase High-Performance Liquid Chromatography (RP-HPLC) technique for the estimation of Lenvatinib in bulk and its dosage form. Methods: To perform this study, we employed a central composite design (CCD) to make method robust and effective to create chromatographic database. The factor screening studies were performed using 2-factor 10-runs. The factors were selected as the mobile phase ratio and buffer pH. Results: The desirability value of the optimized model was found to be 0.869 and The optimized chromatographic condition was achieved on Enable C18 analytical column with 0.01M Ammonium acetate buffer pH 3.84: methanol (33.17:66.83 v/v) as the mobile phase and flow rate of 1 ml min-1 and detection wavelength was set to 240 nm. The retention time of Lenvatinib was found to be 5.122 min. Linearity was established for Lenvatinib in the range of 10-50 µg/ml with a correlation coefficient (r2=0.9995). The accuracy values were found to be in the range of 98–102%. Intraday precision and Interday precision were in prescribed (Less than 0.98% RSD). Robustness was found to be less than 1.22% RSD. Conclusion: The proposed method was useful for best analysis of Lenvatinib in Bulk pharmaceutical dosage forms. Central Composite Design was an effective tool for the proposed RP-HPLC method.


Author(s):  
Ajay I. Patel ◽  
Krupa B. Prajapati ◽  
Swati H. Jolapara ◽  
Amitkumar J. Vyas ◽  
Ashok B. Patel ◽  
...  

The high-Performance Analytical Liquid Chromatography (HPLC) method (AQbD) for routine analysis of Gemfibrozil in dosage form was developed in column C18 using an experimental design. The central composite design (CCD) was adopted in evaluating the responses and robustness of the method. In the project, the combined effect of buffer pH, % organic phase and flow rate, each at five levels, was selected for responses such as retention time and number of theoretical plates, then interpreted and optimized statistically with the help of the surface methodology of response and therefore of the analysis of the constructed models and of the outline graphs was obtained. Acetonitrile: phosphate buffer (pH-4) (59: 41% v / v) as eluent at a flow rate of 1.0ml/min was found to be the optimal condition for obtaining the desired answers.


2009 ◽  
Vol 00 (00) ◽  
pp. 090721051030036-8
Author(s):  
Jaleh Varshosaz ◽  
Solmaz Ghaffari ◽  
Mohammad Reza Khoshayand ◽  
Fatemeh Atyabi ◽  
Shirzad Azarmi ◽  
...  

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