scholarly journals QBD APPROACH TO ANALYTICAL METHOD DEVELOPMENT AND ITS VALIDATION FOR ESTIMATION OF LENVATINIB IN BULK AND PHARMACEUTICAL FORMULATION

2021 ◽  
pp. 183-188
Author(s):  
SACHIN A. BABAR ◽  
SUDHAKAR L. PADWAL
Keyword(s):  
Central Composite Design ◽  
Mobile Phase ◽  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Factor Screening ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Chromatographic Condition ◽  
Central Composite

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.

Method Development and Validation of Degradation Studies of Lenalidomide by RP-HPLC

2021 ◽  
pp. 4281-4286
Author(s):  
Punna Venkateshwarlu ◽  
Mehul M. Patel
Keyword(s):  
Retention Time ◽  
Mobile Phase ◽  
Method Development ◽  
Hplc Method ◽  
Mobile Phase Flow Rate ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
System Suitability ◽  
Wide Range

A simple, accurate, RP HPLC method was developed by this study determination of lenalidomide. This method is developed by Shimadzu LC -2010 HT by using C18 (250 X 4.6 X mm X 5µ) column in solvents Phosphate buffer: Acetonitrile (55:45) v/v as mobile phase and the temperature was maintained at 25°C. The mobile phase flow rate 1ml/min was pumped and sample wavelength was detected at 242nm by ultraviolet -visible spectrophotometer. The retention time was found 2.5 min. The number of theoretical plates and tailing factor for lenalidomide was observed 16199.817 (NLT 2000) and 1.128 (NMT 2). The method was validated for analytical standards such as linearity, accuracy, precision, system suitability and robustness. LOD and LOQ values obtained from regression of lenalidomide 0.058 and 0.174µg/ml. The regression equation of validated method for lenalidomide is Y=5223x+183075. In wide range of 25 to 150 (µg/ml) the linearity was observed. The method was validated and a recovery study indicates accuracy of this method. The Retention time less compared to established methods. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Lenalidomide in bulk drug and in its pharmaceutical dosage forms.

scholarly journals Isocratic RP-HPLC Method for Simultaneous Separation and Estimation of Zofenopril and Hydrochlorthiazide in Pharmaceutical Dosage Forms

2012 ◽  
Vol 9 (2) ◽  
pp. 999-1006 ◽  
Author(s):  
G. S. Devika ◽  
M. Sudhakar ◽  
J. Venkateshwara Rao
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Sodium Hydroxide Solution ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Simultaneous Separation ◽  
Liquid Chromatographic

A simple, rapid, sensitive and accurate isocratic reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the simultaneous determination of Zofenopril and Hydrochlorthiazide in combined dosage form. Chromatographic separation of the two drugs was performed on a Purospher BDS C18 column (250 mm × 4.6 mm id, 5 μm particle size). The mobile phase comprising of acetonitrile methanol: 0.02M NaH22PO4buffer (40:20:40) was delivered at a flow rate of 1.0mL/min. The pH of the mobile phase is adjusted to 7.2 with Sodium hydroxide solution. Detection was performed at 245 nm.The separation was completed within 10 min and the retention time of hydrochlorthiazide is 4.62 and Zofenopril is 6.86 min respectively. Calibration curves were linear with R2between 0.99-1.0 over a concentration range of 100-600 μg/ml for Zofenopril calcium and 50-300 μg/ml for hydrochlorthiazide..The developed method was successfully applied to determi

RP-HPLC Method for Determination of Gemfibrozil using Central Composite Design (CCD)

2021 ◽  
pp. 3009-3014
Author(s):  
Ajay I. Patel ◽  
Krupa B. Prajapati ◽  
Swati H. Jolapara ◽  
Amitkumar J. Vyas ◽  
Ashok B. Patel ◽  
...  
Keyword(s):  
Central Composite Design ◽  
Flow Rate ◽  
High Performance ◽  
Dosage Form ◽  
Hplc Method ◽  
Rp Hplc ◽  
Central Composite ◽  
Theoretical Plates ◽  
Analytical Liquid Chromatography

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.

scholarly journals RP-HPLC Method Development and Validation for Determination of Didanosine in Pharmaceutical Dosage Forms

2019 ◽  
Vol 9 (4-s) ◽  
pp. 343-347
Author(s):  
Sachin Gholve ◽  
Sharddha Gangapure ◽  
Mahesh Birajdar ◽  
Imran Mujewar ◽  
Omprakash G Bhusnure
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
Chromatographic Determination ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines

To develop a simple, cheap, accurate, and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for estimation of Didanosine in pharmaceutical dosage forms. The separation was conducted by using mobile phase consisting of methanol: water in the ratio (30:70). The wavelength was found at 246nm. Agilent 1220 Infinity LC with ezchrome software is used for chromatographic determination. The separation was conducted by using Zebra Eclipse XDB-C-18 (4.6×250×5µm) at the flow rate of 1.0 ml/min using variable wavelength detector. The developed method resulted in didanosine eluting at 4.650 min. The method was found to be linear over the concentration range 2-12µg/ml with coefficient regression R2-0.997. Mean recovery was found to be in the range of 99.99%, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 5 mg/ml and 16 mg/ml respectively. A cheap, accurate, precise, linear and rapid RP-HPLC method was developed and validated for the quantitative estimation of Didanosine as per ICH guidelines. Keywords:-RP-HPLC, Didanosine, Method Validation

scholarly journals A New Approach to the RP-HPLC Method for Simultaneous Estimation of Atorvastatin Calcium and Fenofibrate in Pharmaceutical Dosage Forms

2012 ◽  
Vol 9 (3) ◽  
pp. 1223-1229 ◽  
Author(s):  
S. D. Bhinge ◽  
S. M. Malipatil ◽  
A. Jondhale ◽  
R. Hirave ◽  
A. S. Savali
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Internal Standard ◽  
Reversed Phase ◽  
Hplc Method ◽  
Raw Material ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Forms ◽  
Atorvastatin Calcium ◽  
Rp Hplc

The present manuscript describes the development and validation of an isocratic reverse phase high-performance liquid chromatographic (RP-HPLC) method for the estimation of Atorvastatin calcium and Fenofibrate in raw material and tablet. Atorvastatin Calcium, Fenofibrate and Diclofenac (internal standard) were well separated using a reversed phase column and mobile phase consisting of acetonitrile:KH2PO4(50 mM) (72:28v/v) (pH 4.1). The mobile phase was pumped at 1.0 mL/min flow rate and atorvastatin calcium and fenofibrate were detected by UV-Vis detection at 260 nm. The retention time for atorvastatin calcium, Internal Standard and fenofibrate were 4.34, 5.35 and 12.05 min, respectively. The LOD and LOQ was found to be 1.95 and 4.80 µg/mL for atorvastatin calcium whereas for fenofibrate it was found to be 1.73 and 3.98 µg/mL in mobile phase. The developed method was validated by applying parameters as precision, accuracy, selectivity, reproducibility and system suitability tests.

scholarly journals Method Development and Validation of Polmacoxib in Capsule Dosage Form by RP-HPLC

2021 ◽  
Vol 11 (4-S) ◽  
pp. 59-63
Author(s):  
Anjali Chaudhary ◽  
Meenakshi Dhaiya ◽  
Shaily Tyagi ◽  
Swati Mittal
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Intended Use

A simple and sensitive RP-HPLC method developed for estimation of Polmacoxib in bulk by using a high performance liquid chromatography with PDA detector using Phenomenex luna C18 column (250mmx4.6mm), 5 µm; mobile phase comprises of Water : ACN as (1:1) at the flow rate 1.0 ml/min and the wavelength of detection  238 nm and eluted at 8.12 minutes. The proposed method is validated for specificity, Linearity, Precision, accuracy, ruggedness, and Robustness. All the parameters were found within the acceptable limits. RP-HPLC method was a simple, reliable economic and acceptable and it confirmed that method is suitable for the intended use for routine quality control and assay of drugs. This method is successfully applied for the determination of commercial dosage form capsule preparation. This method is validated as per ICH (International conference on harmonization) Guidelines. Keywords: Polmacoxib, RP-HPLC, ICH, PDA Detector, Precision

A comparative technique using as Joint studying to prove structure and determination the Quantitative estimation of organic compound (Irbesartan) as drug in multicomponent tablet form

2019 ◽  
Vol 9 (o3) ◽  
Author(s):  
Imad Tarek Hanoon ◽  
Abed Mohammed Daheir AL-Joubory 2 ◽  
Marwa Mohamed Saied 3
Keyword(s):  
Mobile Phase ◽  
Chemical Structure ◽  
Quantitative Estimation ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Tablet Form ◽  
Rp Hplc ◽  
Percent Recovery

A simple , specific, accurate and precise RP-HPLC method was developed for determination of Irbesartan (IRB) in pharmaceutical dosage forms in tablets products and sachet using symmetry (L 1 ) column at 30°C . The signal was detected at 225 nm. A mobile phase dissolve 0.5 g of buffer potassium phosphate in 100 ml distilled water and adjust pH 2.7 , methanol and acetonitrile at ratio (40 :30 :30 ) . and flow rate 1.2ml/min -1 at pH=7.2 a mobile phase The percent recovery was detected 101 % and the linearity of concentration was 10-50 µg.ml -1 and supported this method by using (FT.I.R.) spectrum method for organic spectrophotometer to prove the chemical structure of this drug and some physical properties . we are obtained the result is identical of other literature . The proposed method was applied successfully for determination of the IRB in tablets products.

scholarly journals RP-HPLC Determination of Raloxifene in Pharmaceuticl Tablets

2006 ◽  
Vol 3 (1) ◽  
pp. 60-64 ◽  
Author(s):  
P. Venkata Reddy ◽  
B. Sudha Rani ◽  
G. Srinu Babu ◽  
J. V. L. N. Seshagiri Rao
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc

A reverse phase HPLC method is developed for the determination of Raloxifene in pharmaceutical dosage forms. Chromatography was carried out on an inertsil C18 column using a mixture of acetonitrile and phosphate buffer (30:70 v/v) as the mobile phase at a flow rate of 1 mL/min. Detection was carried out at 290 nm .The retention time of the drug was 10.609 min. The method produced linear responses in the concentration range of 0.5-200 µg/mL of Raloxifene. The method was found to be applicable for determination of the drug in tablets.

scholarly journals RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms

2013 ◽  
Vol 49 (2) ◽  
pp. 359-366 ◽  
Author(s):  
Mustafa Çelebier ◽  
Tuba Reçber ◽  
Engin Koçak ◽  
Sacide Altinöz
Keyword(s):  
Method Development ◽  
Internal Standard ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied successfully for the quality control assay of rivaroxaban in tablet dosage form.

scholarly journals Analytical Method Development and Validation of Rp-Hplc Method for Simultaneous Estimation of Pyridoxamine Dihydrochloride and Acetylcysteine in Tablet Dosage Form.

2021 ◽  
Vol 23 (06) ◽  
pp. 992-1000
Author(s):  
Sneha S. Ghule ◽  
◽  
Ashpak M. Tamboli ◽  
Snehal D. Patil ◽  
◽  
...  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
System Suitability ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Pyridoxamine dihydrochloride and Acetylcysteine in the marketed formulation is developed. Chromatography carried out at 30oc temperature on Agilent Zorbax Bonus-RP (250 x 4.6 mm, 5 µ) coloum. Coloum using a mobile phase 0.1% trifluroacetic acid in water: acetonitrile (80:20v/v) with flow rate 1ml/min (DAD scan at 210nm). Validation parameters such as system suitability, linearity, precision, accuracy are considered as reported International Conference on Harmonization guidelines. The retention times for Pyridoxamine dihydrochloride and Acetylcysteine are 2 min and 3.4 min. The linearity range for Pyridoxamine dihydrochloride and Acetylcysteine is 30-70 µg/ml and 180-420 µg/ml. The %RSD for accuracy was found to be less than 2%. Hence the proposed method was found to be accurate, precise, reproducible, and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

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