High‐Performance Liquid Chromatographic Assay of Cyclophosphamide in Raw Material and Parenteral Dosage Forms

1979 ◽  
Vol 68 (9) ◽  
pp. 1144-1146 ◽  
Author(s):  
L.R. Wantland ◽  
S.D. Hersh
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Raw Material ◽  
Liquid Chromatographic

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 High-Performance Liquid Chromatographic Fingerprint for Quality Control of Terminalia arjuna Containing Ayurvedic churna Formulation

2009 ◽  
Vol 92 (4) ◽  
pp. 1016-1020 ◽  
Author(s):  
Sohan S Chitlange ◽  
Prajakta S Kulkarni ◽  
Dada Patil ◽  
Bhushan Patwardhan ◽  
Rabindra K Nanda
Keyword(s):  
Quality Control ◽  
High Performance ◽  
Raw Materials ◽  
High Performance Liquid Chromatographic ◽  
Raw Material ◽  
Terminalia Arjuna ◽  
Hplc Fingerprint ◽  
Ayurvedic Drugs ◽  
Quality Control Tool ◽  
Liquid Chromatographic

Abstract Because Ayurvedic herbal preparations contain a myriad of compounds in complex matrixes, it is difficult to establish quality control standards for raw materials and to standardize finished Ayurvedic drugs. A novel, accurate, and valid fingerprint method was developed using HPLC for quality control of a traditional Ayurvedic Arjuna churna formulation, which is used as a cardiotonic drug. Comprehensive comparison of chromatograms of standardized formulation of Arjuna churna and marketed formulations revealed eight characteristic peaks in chromatograms, which unambiguously confirmed the presence of authentic raw material used in the formulation on the basis of their retention time values and UV data. An HPLC fingerprint was also developed for total sapogenins present in Terminalia arjuna. The six common peaks observed in chromatograms of isolated sapogenins, standardized formulations, and marketed formulations can serve as a quality control tool for qualitative estimation of total saponin glycosides present in an Arjuna churna formulation.

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.

scholarly journals Development and Validation of a Micellar High-Performance Liquid Chromatographic Method for Determination of Risedronate in Raw Material and in a Pharmaceutical Formulation: Application to Stability Studies

2010 ◽  
Vol 93 (4) ◽  
pp. 1228-1235 ◽  
Author(s):  
Mohamed Walash ◽  
Mohamed Metwally ◽  
Manal Eid ◽  
Rania El-Shaheny
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Sodium Dodecyl ◽  
Oxidative Degradation ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Raw Material ◽  
Forced Degradation ◽  
The Stability ◽  
Liquid Chromatographic

Abstract A micellar HPLC method was developed for analysis of the antiosteoporosis drug risedronate. The analysis was carried out using a 250 4.6 mm id, 5 m particle size C18 Waters Symmetry column. The mobile phase consisted of 0.02 M sodium dodecyl sulfate + 0.3 triethylamine + 10 n-propanol, prepared in 0.02 M orthophosphoric acid. The pH of the mobile phase was adjusted to pH 6.0, and it was pumped at a flow rate of 0.7 mL/min with UV detection at 262 nm. The method showed good linearity in the range of 280 g/mL, with an LOD of 0.40 g/mL (1.31 106 M) and an LOQ of 1.21 g/mL. The suggested method was successfully applied for the analysis of risedronate in raw material and a tablet formulation, with average recoveries of 99.91 1.30 and 101.52 0.30, respectively. The stability-indicating capability of the proposed method was proved using forced degradation. By changing the pH of the mobile phase to 4.0, the oxidative degradation product could be separated from risedronate.

scholarly journals Simultaneous Determination of Simvastatin and Ezetimibe in Tablets by HPLC

2009 ◽  
Vol 6 (2) ◽  
pp. 541-544 ◽  
Author(s):  
D. Anantha Kumar ◽  
D. P. Sujan ◽  
V. Vijayasree ◽  
J. V. L. N. Seshagiri Rao
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Ammonium Acetate ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Reverse Phase ◽  
Liquid Chromatographic Method ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of simvastatin and ezetimibe in tablet dosage forms. The separation was effected on a C18 Supelcosil column (250 mm x 4.6 mm; 5µ) using a mobile phase consisting of 0.01 M ammonium acetate buffer and acetonitrile (35:65v/v) at a flow rate of 1 mL/min. The detection was made at 240 nm. The retention times for ezetimibe and simvastatin were 5.9 and 8.5 min respectively. Calibration curves were linear over the ranges of 0.5-40 µg/mL for simvastatin and 2.5-50 µg/mL for ezetimibe. The proposed method was validated as per the ICH and USP guidelines. The method is accurate and precise and found to be suitable for the quantitative analysis of both the drugs individually and in combination in tablet dosage forms.

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