A Rapid RP HPLC Method Development and Validation for the Analysis of Divalproex in Bulk and Pharmaceutical Dosage Forms

Israel, Debra S.; Ganji, Shiny; Kumar, Brijesh

doi:10.5958/2231-5675.2016.00003.x

Asian Jour. Pharmac. Anal.

2016

DOI: 10.5958/2231-5675.2016.00003.x

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A Rapid RP HPLC Method Development and Validation for the Analysis of Divalproex in Bulk and Pharmaceutical Dosage Forms

Debra S. Israel¹,

Shiny Ganji²,

Brijesh Kumar³

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Cited by 5 publications

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Derivative Spectroscopic Method and RP-HPLC Method Development and Validation of Levofloxacin hemihydrate

Sen,

Ravindar,

Jala

et al. 2023

RJPT

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The present work describes the development of a simple, precise and accurate derivative spectroscopic and RP-HPLC method for the estimation of levofloxacin hemihydrate in the tablet dosage form. Levofloxacin hemihydrate showed absorption maxima at 287.36, 287.2 and 296.2nm in zero, first and second-order spectroscopic methods. The RP-HPLC method was optimized by using Orthophosphoric acid: acetonitrile: methanol (50: 20: 30) as solvent at 287nm. The methods showed linearity in the concentration range 1-5 and 2-10 µg/ ml and the correlation coefficient was 0.999 respectively. The method has been validated according to the ICH guidelines. The percentage relative standard deviation was found to be less than 2% in respect of both methods.

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Derivative Spectroscopic Method and RP-HPLC Method Development and Validation of Levofloxacin hemihydrate

Sen,

Ravindar,

Jala

et al. 2023

RJPT

View full text Add to dashboard Cite

show abstract

Analytical Method Development and Validation of Tofisopam in Pure and Pharmaceutical formulation

S. Gawas,

Maste,

S. Suryawanshi

2024

RJPT

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Tofisopam is an anxiolytic used in treatment of anxiety like disorders, prescribed in the dosage of 50mg to 300mg. As the drug is insoluble in water it is necessary to develop an economical and streamlined liquid chromatography for determination of pure and commercial dosage of Tofisopam. The main objective of the work is to develop and validate an RP-HPLC method for determination of Tofisopam as per ICH guidelines. An RP- HPLC method was devised using 0.1% Orthophosphoric acid in water: methanol in the ration 10:90% v/v and validated for parameters such as system suitability, linearity, limit of detection, limit of quantitation, precision, accuracy, assay, robustness, and ruggedness, as per ICH Guidelines. Tofisopam showed the maximum absorbance at 238nm with good system suitability and linearity was entrenched within the range of 10-60µg/ml, with the regression coefficient of 0.9996. The limit of detection and limit of quantitation were found to be 2.75 µg/ml and 8.855µg/ml respectively. Assay was valuated to be 101%, Accuracy was valuated between 98-103%, and %RSD was less the 2% for precision, robustness and ruggedness, so the method is precise and accurate. The method robustness is demonstrated by insignificant variations in absorption values and mobile phase ratio with deliberate alterations. In accordance with the validation results, the procedure is simple, specific, precise, accurate, robust and suitable for routine analysis of Tofisopam in bulk and commercial products.

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Development and Validation of HPTLC Method for the Estimation of Alectinib in Capsule Dosage Form

Dhavale,

Daroi,

Sonawane

et al. 2024

RJPT

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A new, simple, accurate, fast, economic and precise high performance thin layer chromatography (HPTLC) method was developed and validated for the estimation of alectinib in a capsule dosage form. Separation of active ingredient from alectinib capsule was done on pre-coated HPTLC plate (silica gel 60 F254) and mobile phase consisting of Toluene: Methanol: Ethyl acetate: Glacial acetic acid in the ratio of 6:2:2:1v/v/v/v. Analysis of alectinib was carried out at the wavelength of 340nm. This system well-resolved bands for alectinib at a Rf value of 0.4. The current method has been statistically validated in accordance with the ICH Q2 (R1) guidelines. Linearity was found to be in the concentration range of 100-1500ng/band with the correlation coefficient of 0.999. Good accuracy and precision were obtained as revealed from %RSD value less than 2.

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A Rapid RP HPLC Method Development and Validation for the Analysis of Divalproex in Bulk and Pharmaceutical Dosage Forms

Cited by 5 publications

References 0 publications

Derivative Spectroscopic Method and RP-HPLC Method Development and Validation of Levofloxacin hemihydrate

Derivative Spectroscopic Method and RP-HPLC Method Development and Validation of Levofloxacin hemihydrate

Analytical Method Development and Validation of Tofisopam in Pure and Pharmaceutical formulation

Development and Validation of HPTLC Method for the Estimation of Alectinib in Capsule Dosage Form

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