Development and Validation of Rp-HPLC Method for the Determination of Nitazoxanide and Ofloxacin in Combined Pharmaceutical Dosage Forms

Kumar, D B Aruna; Rathi, V. P. Gladis Pushpa; Singh, Vijender

doi:10.21276/irjps.2016.3.4.2

Cited by 3 publications

(3 citation statements)

References 10 publications

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“…Harika M et al, 37 developed a method for estimating nilotinib by using RP-HPLC in bulk and pharmaceutical dosage form. The separation of analyte was carried out on C18 analytical column (250 × 4.6 mm, 5 µ) with isocratic mode.…”

Section: Fig 2: Mechanism Of Tyrosine Kinase Inhibitorsmentioning

confidence: 99%

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2022

IJPSR

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Tyrosine kinase inhibitors generally having a narrow therapeutic window and large inter-patient variability. In order to support its therapeutic drug monitoring, fast and accurate methods are needed to supporting the pharmacokinetic-guided dosing in patients treating with various tyrosine kinase inhibitors (TKIs) either alone or in combination in bulk, formulations or human plasma using HPLC and detection with tandem mass spectrometry (HPLC-MS/MS), gas chromatography with mass spectrometry, spectrofluorimetry and UV-Visible spectrometry. Literature suggested that the methods developed and validated are good for accuracy, precision, and assay for all TKIs studied. These methods are also applied for routine therapeutic drug monitoring and investigator-initiated research. In this review, we described different analytical methods used for the qualitative and quantitative estimation of all TKIs investigated till 2020 in assessing the quality of drugs by using HPLC, LC-MS, HPTLC, UPLC, UV-Visible spectrophotometry, spectrofluorimetry with a huge survey from the research articles published in various pharmaceutical and analytical chemistry journals. From this assessment, these methods were found to be superior based on the quantitative analysis of drugs in API, formulations, biological fluids such as serum and plasma. Detailed validation parameters are also given for the methods that help the researchers select suitable analytical techniques based on the information sought.

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Section: Fig 2: Mechanism Of Tyrosine Kinase Inhibitorsmentioning

confidence: 99%

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2022

IJPSR

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“…CFX is official in British Pharmacopeia (BP), European Pharmacopeia (EP) [1,2] and United States Pharmacopeia (USP) [8], both of them includes HPLC Method for its estimation. Literature review revealed that various analytical methods have been described for the determination of CFX including colorimetric and spectrophotometric [9][10][11][12][13][14][15][16][17][18][19][20][21][22], thin layer chromatography (TLC) [23][24][25][26], capillary electrophoresis [27][28][29], high performance liquid chromatography (HPLC) [30][31][32][33][34][35][36][37][38][39] and electrochemical methods [40][41][42][43] have been developed for the estimation of CFX in pure or in dosage forms. SDM is official in BP, EP [1,2] and United States Pharmacopeia (USP) [8], which includes direct titration for estimation of SDM.…”

Section: Cfx; Is Chemically Known As (6r7r)-7-[[(z)-2-(2-aminothiazol...mentioning

confidence: 99%

Validation of a Novel and Sensitive RP-HPLC Method for Simultaneous Determination of Cefixime Trihydrate and Sodium Benzoate in Powder for Oral Suspension Dosage Form

Hassouna¹

2017

JFSCI

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A novel, specific, precise, simple, and accurate RP-HPLC method is developed and validated for simultaneous determination of Cefixime trihydrate (CFX) and Sodium benzoate (SDM) in powder for oral suspension (POS) dosage form. RP-HPLC method is performed on the Agilent Eclipse XDB C8 column (250 mm X 4.6 mm, 5μm particle size, using buffer solution of pH 2.8 containing 0.02M sodium dihydrogen phosphate: Acetonitrile (50:50 v/v) as the mobile phase at a flow rate of 1.0 mL/min, injection volume 10 µL and UV detection at 229 nm. And the total run time was 7.0 min. Linear relationships are obtained in the ranges of 5-200 µg/mL and 2-40 µg/mL for CFX and SDM, respectively, with significantly different R t values of 2.203 and 3.970 min for CFX and SDM with correlation coefficients (r) >0.9999, limits of detection of 1.36 and 0.21 µgmL -1 and limits of quantitation was 4.14 and 0.64 µgmL -1 for CFX and SDM, respectively. The obtained results for the suggested method were statistically compared with those obtained by official or the reported method for CFX and SDM, respectively using student's-t and F-ratio tests, showing that the methods are accurate and precise. This method is validated according to ICH guidelines and USP requirements for new methods, which include accuracy, precision, specificity, LOD, LOQ, robustness, ruggedness, linearity and range. Hence this RP-HPLC method is suitable for quality control of raw materials and finished products. The accurate determination of low levels of both drugs is very important for the analysis of forensic problems.

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“…Compound which is more hydrophobic will be retained longer on the column than lesser hydrophobic one, based on the hydrophobicity they get separated. Organic and aqueous phases are the two components which are used as mobile phase [3]. As per "World Health Organization" reservation, INH is one the front line agent for the treatment of tuberculosis and INH pertains to the category of nucleoside reverse transcriptase inhibitor [4], with aqueous solubility of 140 mg/ml [5].…”

Section: Introductionmentioning

confidence: 99%

Nano Formulation Analysis: Analytical Method Development of Isoniazid and Simultaneous Estimation of Anti-Tubercular Drugs Isoniazid and Rifampicin by Rp-HPLC

Hakkimane

Guru

2017

Asian J Pharm Clin Res

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Objective: The objective of the study was to develop and validate a simple and reproducible reverse phase high pressure liquid chromatography (RP-HPLC) method for hydrophilic drug isoniazid (INH) to apply for the analysis of the INH in nanoparticle drug formulations. Furthermore, to estimate simultaneously rifampicin (RIF) and INH in combined form. Methods:Isocratic elution with 10 minutes runtime on a C-18 Luna, 5 µ, 100Å, 150 mm column, methanol, and water as mobile phase with detection wavelength at 268 nm was used. INH nanoformulations were prepared by double emulsion solvent evaporation technique. Quantitative analysis of encapsulated drug was estimated via developed RP-HPLC method. Simultaneous estimation for the two drugs was carried out by gradient elution. All chromatographic separation and estimations were obtained on Shimadzu HPLC system. Results:INH eluted with a short retention time (RT) of 4.06 minutes. Method showed good linearity in the range of concentrations 0.01-100 µg/ml. The limit of detection (LOD) and quantification (LOQ) for INH was 0.03 and 0.12 µg/mL, respectively, and developed method has been successfully applied for the analysis of drugs in nanoparticle formulations. Simultaneous estimation of antitubercular drugs INH and RIF showed two separate peaks within specified runtime. Conclusion:Developed method showed good resolved peaks. Since the RT is short, in a shorter duration more samples could be completed and developed method will be easy for analyzing greater number of samples. Analysis of nanoformulation results have shown that this method is simple, reliable, reproducible, hence can be applied for drug delivery analysis.

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Development and Validation of Rp-HPLC Method for the Determination of Nitazoxanide and Ofloxacin in Combined Pharmaceutical Dosage Forms

Cited by 3 publications

References 10 publications

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Validation of a Novel and Sensitive RP-HPLC Method for Simultaneous Determination of Cefixime Trihydrate and Sodium Benzoate in Powder for Oral Suspension Dosage Form

Nano Formulation Analysis: Analytical Method Development of Isoniazid and Simultaneous Estimation of Anti-Tubercular Drugs Isoniazid and Rifampicin by Rp-HPLC

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