scholarly journals Method validation for the simultaneous estimation of three-bioactive components in combined extracts of three hepatoprotective plants using RP-HPLC method

Author(s):  
Mehta Sharuti ◽  
Sharma Anil Kumar ◽  
Singh Rajesh Kumar
2021 ◽  
Vol 11 (5-S) ◽  
pp. 57-62
Author(s):  
Basant Lal ◽  
Manish Jaimini ◽  
Devesh Kapoor

New liquid chromatographic technique was established for the simultaneous estimation of tinidazole, omeprazole and amoxicillin in the fixed dose combination (HP-KIT by Sun Pharma). RP-HPLC elution has performed by using the Phenomenex Luna column (250 mm x 4.6 mm) having internal diameter and the packing material of size 5µm) in isocratic mobile phase of solution A: acetonitrile at a ratio of 80:20 v/v (Solution A consists of Buffer: Acetonitrile: Methanol: Triethylamine in the ratios of 68:22:10:0.01 respectively). The selected flow rate was kept as 1 ml/min and selected wavelength was 230 nm was for detection of the drugs in UV detector. As per the ICH guidelines, the method validation was carried out. Moreover, the different parameters of method such as precision, specificity, linearity, robustness and accuracy were established. The time of retention for the tinidazole, amoxicillin, and omeprazole were 4.021 2.324, and 7.332 minutes respectively. The RP-HPLC approach was robust and accurate, so it is appropriate for repetitive assay of drugs and quality control. This method is effectively used for the assessment of marketable dosage form preparation. Keywords: RP-HPLC, Amoxicillin, Tinidazole, Omeprazole, Method Development, Method Validation.


2018 ◽  
Vol 14 (4) ◽  
pp. 412-418
Author(s):  
Rasmita Patra ◽  
Prakash Narayana Reddy ◽  
N.S. Sampath Kumar ◽  
Vijaya R. Dirisala

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Ramakrishna Kommana ◽  
Praveen Basappa

The present paper describes the development of quick stability indicating RP-HPLC method for the simultaneous estimation of codeine phosphate and chlorpheniramine maleate in the presence of its degradation products, generated from forced degradation studies. The developed method separates codeine phosphate and chlorpheniramine maleate in impurities/degradation products. Codeine phosphate and chlorpheniramine maleate and their combination drug product were exposed to acid, base, oxidation, dry heat, and photolytic stress conditions, and the stressed samples were analysed by proposed method. The proposed HPLC method utilizes the Shimadzu HPLC system on a Phenomenex C18 column (, 5 μ) using a mixture of 1% o-phosphoric acid in water : acetonitrile : methanol (78 : 10 : 12) mobile phase with pH adjusted to 3.0 in an isocratic elution mode at a flow rate of 1 mL/min, at 23°C with a load of 20 μL. The detection was carried out at 254 nm. The retention time of codeine phosphate and chlorpheniramine maleate was found to be around 3.47 min and 9.45 min, respectively. The method has been validated with respect to linearity, robustness, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The developed validated stability indicating HPLC method was found to be simple, accurate, and reproducible for the determination of instability of these drugs in bulk and commercial products.


2012 ◽  
Vol 24 (1) ◽  
pp. 15-22 ◽  
Author(s):  
P. B. Deshpande ◽  
S. V. Gandhi ◽  
N. V. Gaikwad ◽  
K. S. Khandagle

Author(s):  
Navya Sree K S ◽  
Swapnil J Dengale ◽  
Srinivas Mutalik ◽  
Krishnamurthy Bhat

Abstract Background Dronedarone HCl is an anti-arrhythmic drug indicated for atrial fibrillation. Dronedarone HCl(DRN) has a low solubility of 2 µg/mL and 4% bioavailability, thus it is formulated as co-amorphous system to enhance its solubility by using Quercetin(QCT) as coformer. Literature lacks a sensitive, accurate and economic method for simultaneous quantification of DRN and QCT in formulation. Objective To develop a RP-HPLC method for simultaneous estimation of DRN and QCT in DRN-QCT co-amorphous system. Method Co-amorphous system was prepared using solvent evaporation technique using DRN and QCT in 1:1 molar ratio. The separation was achieved on Purospher® STAR C18 (250 mm × 4.6 mm × 5 μm) column with mobile phase comprising of Acetonitrile and 25 mM phosphate buffer pH 3.6 (60:40, % v/v). Results DRN and QCT retained at 6.7 and 3.5 min, respectively. For both molecules, method was developed with a wide linearity range of 0.2–500 µg/mL. LOD for DRN was found to be 0.0013 and 0.0026 µg/mL for QCT. Also, LOQ for DRN was found to be 0.0041 and 0.0078 µg/mL for QCT. Conclusion Method was validated as per ICHQ2R1 guidelines for linearity, precision, accuracy, and robustness. The method was used in simultaneous quantification of DRN and QCT in co-amorphous samples. Highlights The method developed was used for the analysis of content uniformity and solubility samples of co-amorphous system, where the method was able to successfully quantify DRN and QCT. Low detection and quantification limits contribute to sensitivity of the method and wide linearity range assures the robust and precise quantification of molecules.


INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (07) ◽  
pp. 59-68
Author(s):  
H Mahajan ◽  
S Savale ◽  
P Nerkar ◽  

The present study was aimed at developing a Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) method for simultaneous determination of curcumin (CRM) and gefitinib (GFT) in bulk, plasma and brain homogenate. hydrochlorothiazide was used as an internal standard (IS). A new simple, rapid, selective, precise and accurate RP-HPLC method has been developed. The separation was achieved by using C-18 column (Qualisil BDS C18, 250 mm x 4.6 mm I.D.) coupled with a guard column of silica, mobile phase consisted of acetonitrile: water with 0.1% formic acid (30:70 v/v). The flow rate was 0.2 ml/min and the drug was detected using PDA detector at the wavelength of 242 nm. The experimental conditions, including the diluting solvent, mobile phase composition, column saturation and flow rate, were optimised to provide high-resolution and reproducible peaks. The method was developed and tested for linearity range of 10-60 μg/mL for bulk analysis and 200-800 ng/mL for plasma and brain homogenate. The developed method was validated as per ICH guidelines, in terms of linearity, application of the proposed method to bulk sample, recovery, precision, repeatability, ruggedness, sensitivity (LOD and LOQ) and robustness and stability study (short and long-term stabilities, freeze/thaw stability, post-preparative). The low value of % RSD showed that the method was precise within the acceptance limit of 2%. The developed method was successfully applied for the analysis of the drug in bulk as well as various marketed formulation and drug in plasma and brain distribution studies.


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