Development and Validation of Stability Indicating Method for Simultaneous Estimation of Esomeprazole and Levosulpiride by HPTLC using Experimental Design

2020 ◽  
Vol 5 (3) ◽  
pp. 213-220
Author(s):  
M.M. Pandey ◽  
K.B. Prajapati ◽  
A.J. Vyas ◽  
A.M. Patel ◽  
N.K. Patel ◽  
...  
Keyword(s):  
Factorial Design ◽  
Desirability Function ◽  
Linear Regression Analysis ◽  
Full Factorial Design ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating Method ◽  
Esomeprazole Magnesium ◽  
Full Factorial

The present study examines simultaneous multiple response optimization using desirability function for the development of an HPTLC method to detect esomeprazole magnesium trihydrate and levosulpiride in pharmaceutical dosage form. HPTLC separation was performed on aluminium plates pre-coated with silica gel 60 F254 as the stationary phase using ethyl acetate:methanol:toluene:ammonia (7:1.5:1.5:0.1% v/v/v) as the mobile phase. Full factorial design applied for the optimization of degradation condition. Esomeprazole magnesium trihydrate and levosulpiride were subjected to acid, alkali hydrolysis, oxidation and photodegradation. Experimental full factorial design has been used during forced degradation to determine significant factors responsible for degradation and to optimize degradation conditions reaching maximum degradation. 32 and 23 full factorial design has been used for optimization of chromatographic condition in acid and base degradation study, respectively. Quantification was achieved based on a densitometric analysis of esomeprazole magnesium trihydrate and levosulpiride over the concentration range of 800-4000 ng/band and 1500-7500 ng/band, respectively at 254 nm. The method yielded compact and well-resolved bands at Rf of 0.70 ± 0.02 and 0.32 ± 0.02 for esomeprazole magnesium trihydrate and levosulpiride, respectively. The linear regression analysis for the calibration plots produced r2 = 0.9967 and r2 = 0.9981 for esomeprazole magnesium trihydrate and levosulpiride, respectively. Method is validated as per ICH (Q2)R1 guideline.

Application of 32 Full Factorial Design and Desirability Function for Optimizing The Manufacturing Process for Directly Compressible Multi-Functional Co-Processed Excipient

2020 ◽  
Vol 17 (6) ◽  
pp. 523-539
Author(s):  
Jalpa Patel ◽  
Dhaval Mori
Keyword(s):  
Factorial Design ◽  
Spray Drying ◽  
Desirability Function ◽  
Full Factorial Design ◽  
Angle Of Repose ◽  
P Value ◽  
Independent Variables ◽  
Full Factorial ◽  
32 Full Factorial Design ◽  
Response Variables

Background: Developing a new excipient and obtaining its market approval is an expensive, time-consuming and complex process. Compared to that, the co-processing of already approved excipients has emerged as a more attractive option for bringing better characteristic excipients to the market. The application of the Design of Experiments (DoE) approach for developing co-processed excipient can make the entire process cost-effective and rapid. Objective: The aim of the present investigation was to demonstrate the applicability of the DoE approach, especially 32 full factorial design, to develop a multi-functional co-processed excipient for the direct compression of model drug - cefixime trihydrate using spray drying technique. Methods: The preliminary studies proved the significant effect of atomization pressure (X1) and polymer ratio (microcrystalline cellulose: mannitol - X2) on critical product characteristics, so they were selected as independent variables. The angle of repose, Carr’s index, Hausner’s ratio, tensile strength and Kuno’s constant were selected as response variables. Result: The statistical analysis proved a significant effect of both independent variables on all response variables with a significant p-value < 0.05. The desirability function available in Design Expert 11® software was used to prepare and select the optimized batch. The prepared co-processed excipient had better compressibility than individual excipients and their physical mixture and was able to accommodate more than 40 percent drug without compromising the flow property and compressibility. Conclusion: The present investigation successfully proved the applicability of 32 full factorial design as an effective tool for optimizing the spray drying process to prepare a multi-functional co-processed excipient.

scholarly journals Development and Validation of a Stability Indicating RP-HPLC Method for the Determination of Two Sun Protection Factors (Koptrizon and Tinosorb S) in Topical Pharmaceutical Formulations Using Experimental Designs

2013 ◽  
Vol 2013 ◽  
pp. 1-12 ◽  
Author(s):  
Chinmoy Roy ◽  
Jitamanyu Chakrabarty
Keyword(s):  
Factorial Design ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Full Factorial Design ◽  
Plate Count ◽  
Forced Degradation ◽  
Solution Stability ◽  
Stability Indicating ◽  
Full Factorial

A novel, simple, validated stability indicating HPLC method was developed for determination of Koptrizon and Tinosorb S. Stability indicating power of the method was established by forced degradation study. The chromatographic separation was achieved with Waters X Bridge column, by using mobile phase consisting of a mixture of acetonitrile : tetrahydrofuran : water (38 : 38 : 24, v/v/v). The method fulfilled validation criteria and was shown to be sensitive, with limits of detection (LOD) and quantitation (LOQ) of 0.024 and 0.08 μg  for Koptrizon and 0.048 and 0.16 μg  for Tinosorb S, respectively. The developed method is validated for parameters like precision, accuracy, linearity, solution stability, specificity, and ruggedness as per ICH norms. Design expert with ANOVA software with linear model was applied and a 23 full factorial design was employed to estimate the model coefficients and also to check the robustness of the method. Results of the two-level full factorial design, 23 with 10 runs including two-centre-point analysis based on the variance analysis (ANOVA), demonstrated that all three factors, as well as the interactions between retention time of Koptrizon, Tinosorb S, and USP plate count for Koptrizon, are statistically significant.

scholarly journals A STATISTICAL APPROACH TO DEVELOPMENT OF TASTE MASKED EFFERVESCENT TABLETS OF SILDENAFIL CITRATE CONTAINING KYRON T134

2020 ◽  
pp. 135-143
Author(s):  
NISHANT OZA ◽  
SWATI SAGAR ◽  
AKRUTI KHODAKIYA ◽  
ASIT SAHU
Keyword(s):  
Factorial Design ◽  
Influence Factor ◽  
Graphical Representation ◽  
Drug Loading ◽  
Linear Regression Analysis ◽  
Full Factorial Design ◽  
Sildenafil Citrate ◽  
Content Uniformity ◽  
Wetting Time ◽  
Full Factorial

Objective: The aim of present work was to mask the bitter taste of sildenafil citrate by preparing drug resin complex (DRC) and develop sildenafil citrate 100 mg effervescent tablets. Methods: Sildenafil citrate and kyron T134 complexes were prepared at different conditions and evaluated for taste and drug loading. Optimized DRC was use to formulate the dispersible tablet by direct compression technique. A 32 full factorial design was use to study the effect of effervescent agent (X1) and croscarmellose sodium (X2) on dispersion time (Y1) and wetting time (Y2). Factorial batches were also evaluated for thickness, hardness, content uniformity, friability, in vitro drug release and stability studies. Multiple linear regression analysis, ANOVA and graphical representation of the influence factor by 3D plots were performing by using sigma plot 11.0. A Check point batch was design according to the results of desirability value and evaluated for all the parameter Results: FT-IR study confirm that sildenafil citrate and kyron T134 were compatible with each other. Among the various DRC batch B29 was found with less bitter and give a more drug loading. Checkpoint batch showed no significance difference between predicted value and actual value for dispersion time and wetting time and it was found stable during stability study. Conclusion: Sildenafil citrate bitter tast was masked by kyron T134 and full factorial design result was indicate that independent variables have significant effect on dependent variables

scholarly journals Dairy Wastewater Treatment with Organic Coagulants: A Comparison of Factorial Designs

Water ◽  
2021 ◽  
Vol 13 (16) ◽  
pp. 2240
Author(s):  
Gustavo Lopes Muniz ◽  
Magno dos Santos Pereira ◽  
Alisson Carraro Borges
Keyword(s):  
Factorial Design ◽  
Desirability Function ◽  
Oxygen Demand ◽  
Experimental Tests ◽  
Full Factorial Design ◽  
Dairy Wastewater ◽  
Coagulant Dosage ◽  
Response Optimization ◽  
Factorial Effects ◽  
Full Factorial

Optimization of coagulant dosage and pH to reduce the turbidity and chemical oxygen demand (COD) of synthetic dairy wastewater (SDW) was investigated using a full factorial design (FFD) and full factorial design with center point (FFDCP). Two organic coagulants, polyacrylamide (PAM) and Tanfloc were used. The optimal values of coagulant dosage and pH were determined using a multiple response optimization tool and desirability function. The results obtained revealed that the optimum condition for removing turbidity and COD were at pH 5.0 using 50 mg L−1 of coagulant. The same optimum point was obtained in both experimental designs, indicating a good agreement between them. In optimum conditions, the expected removal of turbidity was above 98% with PAM and above 95% with Tanfloc. The estimated COD removal was above 72% with PAM and above 65% with Tanfloc. The addition of center points with replicates in the factorial design allowed to obtain the estimate of the experimental error with a smaller number of runs, allowing to save time and cost of the experimental tests. Moreover, the addition of center points did not affect the estimates of the factorial effects and it was possible to verify the effect of curvature, allowing obtaining information about the factors at intermediate levels.

Formulation of Extended-Release Beads of Lamotrigine Based on Alginate and Cassia fistula Seed Gum by QbD Approach

2020 ◽  
Vol 17 (5) ◽  
pp. 422-437
Author(s):  
Dixita Jain ◽  
Akshay Sodani ◽  
Swapnanil Ray ◽  
Pranab Ghosh ◽  
Gouranga Nandi
Keyword(s):  
Drug Release ◽  
Factorial Design ◽  
Extended Release ◽  
Polymer Concentration ◽  
Green Manufacturing ◽  
Full Factorial Design ◽  
Cassia Fistula ◽  
Negative Environmental Impact ◽  
Seed Gum ◽  
Full Factorial

Aim: This study was focused on the formulation of the multi-unit extended-release peroral delivery device of lamotrigine for better management of epilepsy. Background: The single-unit extended-release peroral preparations often suffer from all-or-none effect. A significant number of multi-unit delivery systems have been reported as a solution to this problem. But most of them are found to be composed of synthetic, semi-synthetic or their combination having physiological toxicity as well as negative environmental impact. Therefore, fabrication and formulation of multi-unit extended-release peroral preparations with natural, non-toxic, biodegradable polymers employing green manufacturing processes are being appreciated worldwide. Objective: Lamotrigine-loaded extended-release multi-unit beads have been fabricated with the incorporation of a natural polysaccharide Cassia fistula seed gum in calcium-cross-linked alginate matrix employing a simple green process and 23 full factorial design. Methods: The total polymer concentration, polymer ratio and [CaCl2] were considered as independent formulation variables with two different levels of each for the experiment-design. The extended-release beads were then prepared by the ionotropic gelation method using calcium chloride as the crosslinkerions provider. The beads were then evaluated for drug encapsulation efficiency and drug release. ANOVA of all the dependent variables such as DEE, cumulative % drug release at 2h, 5h, 12h, rate constant and dissolution similarity factor (f2) was done by 23 full factorial design using Design-Expert software along with numerical optimization of the independent variables in order to meet USP-reference release profile. Results: The optimized batch showed excellent outcomes with DEE of 84.7 ± 2.7 (%), CPR2h of 8.41± 2.96 (%), CPR5h of 36.8± 4.7 (%), CPR12h of 87.3 ± 3.64 (%) and f2 of 65.9. Conclusion: This approach of the development of multi-unit oral devices utilizing natural polysaccharides might be inspiring towards the world-wide effort for green manufacturing of sustained-release drug products by the QbD route.

scholarly journals Shear strength optimization for FSSW AA6060-T5 joints by Taguchi and full factorial design

2020 ◽  
Vol 9 (6) ◽  
pp. 16072-16079
Author(s):  
C.A.G. Aita ◽  
I.C. Goss ◽  
T.S. Rosendo ◽  
M.D. Tier ◽  
A. Wiedenhöft ◽  
...  
Keyword(s):  
Shear Strength ◽  
Factorial Design ◽  
Full Factorial Design ◽  
Full Factorial
Sign in / Sign up

Export Citation Format

Share Document