scholarly journals Validated High Performance Liquid Chromatographic Quantification of Pamidronate in Bulk and Dosage Form

2020 ◽  
pp. 1-6
Author(s):  
Sherif A. Abdel- Gawad ◽  
Aymen Khalid Al Suwailem ◽  
Sami Salem AlShowiman
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Match Method ◽  
Mobile Phases ◽  
Validation Parameters ◽  
Chromatographic Detection ◽  
Liquid Chromatographic ◽  
Assay Conditions

Aims: The studied drug is lacking the presence of chromophore so a reaction with NBD-Cl is optimized to facilitate its chromatographic detection, so the main aim of the work is to quantify pamidronate in a sensitive and accurate way either in bulk or dosage forms. Methodology: The quantification of this group of drugs is a challenging task as they lack the presence of chromophore groups in their structure. The proposed method depends on the chromatographic quantification of the studied drug after its derivatization via its reaction with 4-Chloro-7-nitro-2,1,3-benzoxazole and the product is separated on ODS C18 column (5 µm, 15 cm x 5 mm, i.d.) as a stationary phase and methanol : water (8:2, v/v) as a mobile phase. The flow rate was 1 ml/min. Results: The studied drug can be determined in the range of 900 - 3000 ng/mL after optimizing the assay conditions to get optimum stationary – mobile phases match. Method validation is performed according to USP-guidelines and different validation parameters like, linearity, accuracy, precision and robustness are calculated and found to be excellent. Conclusion: The proposed method is accurate, sensitive and can be applied for the routine analysis of pamidronate in quality control laboratories.

scholarly journals Development of a Simple, Sensitive and Rapid Quantitative Analytical Method for Lomefloxacin by High Performance Liquid Chromatography

1970 ◽  
Vol 4 (1) ◽  
pp. 69-73 ◽  
Author(s):  
Mohammad Shah Amran ◽  
Mohammad Rumman Hossain ◽  
Farhad Mohammad Amjad ◽  
Sania Sultana ◽  
Mohammad Abdullahil Baki ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Absorption Maximum ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Companies ◽  
Pharmaceutical Dosage Form ◽  
Mobile Phases ◽  
Liquid Chromatographic

An attempt has been made to develop a simple, sensitive and rapid high performance liquid chromatographic (HPLC) method of analysis for lomefloxacin as in pharmaceutical dosage form using 0.025 M phosphoric acid and acetonitrile (80:20) as mobile phases. The mobile phase was used as solvents to dissolve lomefloxacin and 0.0122 mg/mL stock solution was prepared. Lomefloxacin solution was scanned with UV-spectrophotometer and the absorption maximum (λmax) was found to be 287 nm. This method was successfully applied to five eye drop dosage forms of lomefloxacin encoded as pp1, pp2, pp3, pp4 and pp5 marketed by five different pharmaceutical companies and the result was found to be satisfactory and reproducible. The method was validated by spiked recovery experiments and shown to be linear for lomefloxacin. The method can be used for routine analysis in both research laboratories, and pharmaceutical and chemical industries to analyze the drugs and chemicals without any interference by the excipients.   Key words: Lomefloxacin; HPLC; Analysis; Reproducible. DOI: http://dx.doi.org/10.3329/sjps.v4i1.8871 SJPS 2011; 4(1): 69-73

scholarly journals Development and Validation of Ultraviolet and Reverse Phase-high Performance Liquid Chromatographic Method for Estimation of Cilnidipine

2021 ◽  
pp. 51-58
Author(s):  
Biswajit Samantaray ◽  
Jagannath Panda ◽  
Satyapriya Mahapatra ◽  
Kajal Ray ◽  
Satish Kanhar
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Uv Spectroscopy ◽  
Wave Length ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Validation Parameters ◽  
Validation Tests ◽  
Development And Validation ◽  
Liquid Chromatographic

Aim: The current experiment was to develop and validate a straight forward RP-HPLC methodology for the determination of Cilnidipine. Methodology: UV spectroscopy was used to estimate Cilnidipine. Action separation of Cilnidipine was achieved by employing a C18 column. Mobile phase combination of methanol: water (90:10 v/v) was tense at the flow of 1 ml/min. Detection was performed at 241 nm. Validation parameters were evaluated in line with the International conference on harmonization (ICH) Q2R1 guidelines. Results: The standardization curve was linear within the varying concentration of 2-10 mg/ml for Cilnidipine with parametric statistic (r2) equal to 0.999. The tactic was found to be accurate (101.66% recovery), precise (intraday, 1.65 and inter day, 1.38) and robust (% RSD was calculated to be 0.66, 0.58 and 0.81 for variation in mobile phase composition, wave length and flow velocity respectively) for the analysis of Cilnidipine. Conclusion: The developed method has passed all the validation tests and can be successfully applied to estimate the presence of Cilnidipine in bulk as well as in pharmaceutical formulations.

Analysis of Sucrose Esters by HPLC Using Charged Aerosol Detector

2012 ◽  
Vol 554-556 ◽  
pp. 1962-1966 ◽  
Author(s):  
Xiao Wen Miao ◽  
Zhi Dong Chang ◽  
Wen Jun Li ◽  
Rong Rong Zhao ◽  
Bin Dong ◽  
...  
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Sucrose Esters ◽  
Phase Compensation ◽  
Charged Aerosol ◽  
Liquid Chromatographic Method ◽  
Gradient Composition ◽  
C 30 ◽  
Liquid Chromatographic

A high performance liquid chromatographic method has been developed for separation and quantitation of sucrose esters using charged aerosol detection (CAD) combined with mobile phase compensation. Two Acclaim120 C18 columns (75×3.0mm, 3μm) and the gradient composition (0 min – 72% A + 25% B + 3%C, 7.5 min – 75% A + 25% B + 3%C, 19.5 min – 97% A + 3%C, 30 min – 97% A + 3%C, where A is methanol, B is water and C is tetrahydrofuran) were applied. A precisely inverse gradient composition (0 min – 97% A + 3%C, 7.5 min – 97% A + 3%C, 19.5 min – 72% A + 25% B + 3%C, 30 min – 72% A + 25% B + 3%C) was also used. The mobile phase compensation was performed by mixing of the column effluent with the mobile phase of exactly reverse composition provided by a second pump before introduction into the CAD. Introduction

scholarly journals Development of a New High-Performance Liquid Chromatographic Method for the Determination of Ceftazidime

2008 ◽  
Vol 91 (4) ◽  
pp. 739-743 ◽  
Author(s):  
Andréia de Haro Moreno ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Calibration Graph ◽  
Raw Material ◽  
Relative Standard ◽  
Validation Parameters ◽  
Liquid Chromatographic

Abstract A rapid, accurate, and sensitive high-performance liquid chromatographic (HPLC) method was developed and validated for the determination of ceftazidime in pharmaceuticals. The method validation parameters yielded good results and included range, linearity, precision, accuracy, specificity, and recovery. The excipients in the commercial powder for injection did not interfere with the assay. Reversed-phase chromatography was used for the HPLC separation on a Waters C18 (WAT 054275; Milford, MA) column with methanolwater (70 + 30, v/v) as the mobile phase pumped isocratically at a flow rate of 1.0 mL/min. The effluent was monitored at 245 nm. The calibration graph for ceftazidime was linear from 50.0 to 300.0 g/mL. The values for interday and intraday precision (relative standard deviation) were <1. The results obtained by the HPLC method were calculated statistically by analysis of variance. We concluded that the HPLC method is satisfactory for the determination of ceftazidime in the raw material and pharmaceuticals.

scholarly journals Stability Indicating HPLC-ECD Method for the Analysis of Clarithromycin in Pharmaceutical Dosage Forms: Method Scaling versus Re-Validation

2019 ◽  
Vol 87 (4) ◽  
pp. 31 ◽  
Author(s):  
Makoni ◽  
Chikukwa ◽  
Khamanga ◽  
Walker
Keyword(s):  
High Performance ◽  
The United States ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Analytical Column ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Run Time ◽  
Liquid Chromatographic

An isocratic high-performance liquid chromatographic method using electrochemical detection (HPLC-ECD) for the quantitation of clarithromycin (CLA) was developed using Response Surface Methodology (RSM) based on a Central Composite Design (CCD). The method was validated using International Conference on Harmonization (ICH) guidelines with an analytical run time of 20 min. Method re-validation following a change in analytical column was successful in reducing the analytical run time to 13 min, decreasing solvent consumption thus facilitating environmental and financial sustainability. The applicability of using the United States Pharmacopeia (USP) method scaling approach in place of method re-validation using a column with a different L–designation to the original analytical column, was investigated. The scaled method met all USP system suitability requirements for resolution, tailing factor and % relative standard deviation (RSD). The re-validated and scaled method was successfully used to resolve CLA from manufacturing excipients in commercially available dosage forms. Although USP method scaling is only permitted for columns within the same L-designation, these data suggest that it may also be applicable to columns of different designation.

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