Analytical Method Development and Validation of RP-HPLC Method for Simultaneous Estimation of N-acetyl cysteine and Cefexime from its Fixed Dose Combination

2016 ◽  
Vol 9 (7) ◽  
pp. 835
Author(s):  
Janhavi Dabir ◽  
Elizabeth Mary Mathew ◽  
Sudheer Moorkoth
Keyword(s):  
Analytical Method ◽  
Method Development ◽  
Hplc Method ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Dose Combination ◽  
Development And Validation

scholarly journals Simultaneous estimation of Curcumin and Gefitinib in bulk by using RP-HPLC technique with PDA detector

2018 ◽  
Vol 10 (1) ◽  
pp. 1-8
Author(s):  
Sagar Kishor Savale
Keyword(s):  
Chromatographic Method ◽  
Method Development ◽  
Estimation Method ◽  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Dose Combination ◽  
Hplc Method Development ◽  
Development And Validation

Plan: RP-HPLC method development and validation for the simultaneous estimation of curcumin and Gefitinib in bulk. Preface: RP-HPLC chromatographic method the been widely employed in the determination of individual components in a mixture or fixed dose combination. For the ternary mixture containing Curcumin and Gefitinib, no chromatographic method for simultaneous evaluation has been reported so far. Thus our aim is to develop a simultaneous estimation method for curcumin and gefitinib by using an RP-HPLC method using a PDA detector. Methodology: The method was validated as per ICH guidelines. The recovery studies confirmed the accuracy and precision of the method. Outcome: The proposed method was found to be accurate, repeatability and consistent. It was successfully applied for the analysis of the drug in the marketed formulation and could be effectively used for the routine analysis of formulation containing the drug without any alteration in the chromatography conditions.

scholarly journals Analytical method development and validation for simultaneous estimation of Fimasartan Potassium Trihydrate and Cilnidipine in synthetic mixture by HPLC for the treatment of hypertension stage-II

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Radhika G. Sojitra ◽  
Urvi J. Chotaliya
Keyword(s):  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
Cost Effective ◽  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Method Development And Validation ◽  
Dose Combination ◽  
Development And Validation

Abstract Background A specific, accurate, precise, robust, and cost-effective HPLC method was developed and validated for quantitative analysis of Fimasartan Potassium Trihydrate and Cilnidipine in fixed-dose combination. The isocratic elution was accomplished by Symmetry C18 column (150 mm × 4.6 mm, 5 µm) at 25 °C. Mobile phase composition is Methanol: Acetonitrile: Potassium Dihydrogen Phosphate buffer (pH 3) (60:05:35%v/v/v) at a flow rate of 1.0 mL/min, injection volume 20 µL with DAD detection at 240 nm. Result Fimasartan Potassium Trihydrate and Cilnidipine were eluted with retention time 2.65 min and 5.51 min respectively. This method was validated as per ICH guideline (Q2 R1). The calibration plots were over the concentration range of 15–90 μg/mL and 2.5–15 μg/mL for Fimasartan Potassium Trihydrate and Cilnidipine with correlation coefficient 0.9992 and 0.9989 respectively. Accuracy was obtained between 99.51–101.65% and 100.06–101.20% for Fimasartan Potassium Trihydrate and Cilnidipine respectively. LOD were found to be 0.97 μg/mL and 0.57 μg/mL and LOQ were found to be 2.95 μg/mL and 1.75 μg/mL for Fimasartan Potassium Trihydrate and Cilnidipine respectively. Conclusion The results showed that the developed method is reliable for the routine analysis for simultaneous determination of Fimasartan Potassium Trihydrate and Cilnidipine.

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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