A New Simultaneous Determination of Rosuvastatin Calcium and its Lactone Impurity by Reverse Phase HPLC method

A simple, precise, accurate and reproducible method has been developed and validated for the estimation of Telmisartan and Rosuvastatin Calcium in their combined tablet dosage form using solvent extraction method followed by UV spectrophotometry. The absorbance was measured at 243.8nm and 295.3nm for Rosuvastatin and Telmisartan respectively. Linearity was found over the concentration range 5-25 micro gram per ml. The solvents used for the estimation were methanol for Telmisartan and phosphate buffer for Rosuvastatin. The method was statistically validated for accuracy, precision, linearity, LOD and LOQ according to ICH guidelines and can be used for analysis of combined dosage form as well as for the individual drugs.

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Development and Validation of a Solvent Extraction UV Spectrophotometric Method for the Estimation of Rosuvastatin Calcium and Telmisartan in Combined Dosage Form

Jose

Nair

Kuttichan

et al. 2022

RJPT

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RP-HPLC Method Development for Simultaneous Estimation of Oral Iron Chelator Deferiprone and its related Impurity

Sutar,

Patil,

Marchande

et al. 2023

RJPT

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Purpose: This study aims to develop and validate a RP-HPLC method for simultaneous estimation of deferiprone and its synthesized impurity. Method: Structure of impurity was confirmed by spectral analysis while their purity was confirmed by HPLC analysis. The chromatographic separation was achieved on Agilent Zorbax Bonus-RP (250 x 4.6mm, 5µ) using mobile phase of 20 ACN-80 0.1% TFA. Detection was carried out at 280 nm using PDA detector with flow rate of 1 ml/min and temperature of 30℃. Result: The method was validated as per ICH guidelines. The percent recovery was found to be within limit and %RSD for deferiprone and the impurity was found to be 0.09 and 0.48. The standard curve was linear over the concentration range of 60-140µg/ml and shows correlation coefficient (r2) of 1. The LOD and LOQ values for deferiprone were found to be 0.21µg/ml and 0.62µg/ml respectively. The method was found to be robust even by change in flow rate of ±0.2ml/min. Conclusion: Validation studies demonstrated that the proposed HPLC method is specific, reliable, rapid and reproducible. The developed method can be successfully employed for routine analysis for deferiprone in pharmaceutical dosage form.

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A New Zero Cross Technique for Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in Tablets by UV Derivative Spectroscopic Method

Pranati,

Rani,

Pravallika

2023

AJPA

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A Simple and reliable Zero cross technique for simultaneous estimation of Rosuvastatin Calcium and Fenofibrate in tablets by using UV derivative method was developed. The quantitative determination of the drugs was carried out using the Zero cross values measured at 235nm and 273nm for Rosuvastatin Calcium and Fenofibrate respectively. The Calibration curves constructed at these wavelengths for the determination of the linearity in the concentration range of 5-25µg/mlfor both the selected drugs. The low relative standard deviation values indicate good precision and higher recovery values indicate accuracy of the proposed method. The developed zero cross technique was found to be simple, accurate, precise, specific, sensitive and reproducible which can be directly and easily applied tomarketed formulations.

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A New Simultaneous Determination of Rosuvastatin Calcium and its Lactone Impurity by Reverse Phase HPLC method

Cited by 5 publications

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Development and Validation of a Solvent Extraction UV Spectrophotometric Method for the Estimation of Rosuvastatin Calcium and Telmisartan in Combined Dosage Form

Development and Validation of a Solvent Extraction UV Spectrophotometric Method for the Estimation of Rosuvastatin Calcium and Telmisartan in Combined Dosage Form

RP-HPLC Method Development for Simultaneous Estimation of Oral Iron Chelator Deferiprone and its related Impurity

A New Zero Cross Technique for Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in Tablets by UV Derivative Spectroscopic Method

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