Development and Validation of a Complexometric Titration Method for the Determination of Rosuvastatin Calcium in Raw Material

Baldut, Mariela; Bonafede, Silvina L.; Petrone, Luciana; Simionato, Laura D.; Segall, Adriana Inés

doi:10.9734/air/2015/19843

Cited by 6 publications

(7 citation statements)

References 21 publications

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“…Literature survey revealed that rosuvastatin calcium has been determined by spectrophotometric methods [4][5] , complexometric titration method 6 , LC-MS 7 , Stability indicating methods [8][9][10][11] , RP-HPLC [12][13][14][15] etc. Present study involves development and validation of a simple RP-HPLC method for the determination of rosuvastatin calcium from its transdermal dosage form.…”

Section: Quick Response Codementioning

confidence: 99%

Untitled

2018

IJPSR

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A RP-HPLC method was developed for estimation of rosuvastatin calcium and validated as per ICH guidelines. The estimation was carried out on C-18 Reliant (4.6 × 250 mm, 5 µm) column using a filtered and degassed mixture of acetonitrile: phosphate buffer pH 2.6 (in the ratio 70:30) as the mobile phase at a flow rate of 1.0 ml/min. The detection was carried out at wavelength of 241 nm. The method was validated for linearity, specificity, accuracy, precision, sensitivity and robustness as per ICH norms. The retention time for the drug was 3.35 min. The method produced linear responses in the concentration range of 2-20 μg/ml with correlation coefficient (r 2) of 0.998. The method developed was found to be simple, rapid, precise accurate and reproducible and can be used for routine analysis of rosuvastatin calcium. Diffusion procedure was performed using pig ear skin as diffusion barrier to characterize rosuvastatin calcium release rate from drug-in-adhesive patch and further analyzed by developed RP-HPLC method. The validated method was found to be specific for estimation of rosuvastatin calcium from its transdermal dosage form. The short run time and the possibility of analysis of a large number of samples makes it a suitable method for analysis and quality control of pharmaceutical preparations containing rosuvastatin calcium. FIG. 1: CHEMICAL STRUCTURE OF ROSUVASTATIN CALCIUM

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Section: Quick Response Codementioning

confidence: 99%

Untitled

2018

IJPSR

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“…Also, it was analyzed by different chromatographic methods such as HPTLC [11][12][13], HPLC [14][15][16][17], UPLC [18,19], and LC-MS/MS methods [20,21]. Rosuvastatin calcium was determined either alone or in its different combined dosage forms by several methods including titrimetric [22], different spectrophotometric [23][24][25][26][27][28][29], spectrofluorimetric [30], HPTLC [31][32][33][34] and HPLC [35][36][37][38] methods.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of bisoprolol fumarate and rosuvastatin calcium in a new combined formulation by validated RP-HPLC

et al. 2019

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A simple, specific, and precise RP-HPLC method was developed and validated for simultaneous determination of Bisoprolol fumarate (BIS) and Rosuvastatin calcium (ROS) in new formulated tablets. The developed RP-HPLC method depended on chromatographic separation using C18 column (150×4.6 mm, 0.5 μm) with mobile phase consisted of acetonitrile and 0.05 aqueous solution of orthophosphoric acid at the ratio of 65:35 % (v:v) with a flow rate of 1 mL/min and UV detection was carried out at 230 nm. Factors affecting the developed methods were studied and optimized and the retention times for BIS and ROS were found to be 2.758 and 4.974 min, respectively. Linearity of the proposed method was observed over a concentration range 0.2-50 μg/mL for each of BIS (r = 0.9999) and ROS (r = 0.9998). The proposed method was successfully applied for the determination of the studied drugs in their bulk powder, laboratory prepared mixtures and in the formulated tablets. The developed method is the first chromatographic method for determination of those drugs and showed no significant difference when compared with the reported methods.

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“…Published literature showed that various methods have been developed for the quantitative estimation of ROSCa either individually or simultaneously including spectrophotometric [3][4][5][6][7][8][9][10], capillary electrophoresis [11], liquid chromatography (HPLC, UPLC) with UV detection or mass spectrometry [12][13][14][15][16][17][18][19][20], complexometric titration [21], thin layer chromatography (TLC) [22][23][24][25], electrochemical [26][27][28], chemometric [29] and spectrofluorimetric methods [30] have been reported for the determination of ROS-Ca in pure, dosage forms or in physiological fluids.…”

Section: Introductionmentioning

confidence: 99%

Novel Spectrophotometric Methods for Simultaneous Determination of Rosuvastatin Calcium, Timolol Maleate and Diclofenac Sodium in Pharmaceutical Ternary Mixture and Spiked Human Plasma

Hassouna

Salem

2019

JPRI

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Three sensitive, times saving, precise and accurate spectrophotometric techniques have been established and confirmed for the simultaneous determination of ternary admixture of rosuvastatin calcium (ROSCa), timolol maleate (TIM) and diclofenac sodium (DICNa). Method A, first derivative of ratio spectra spectrophotometric (1st DD) which is the most simple simplest one. Using the spectrum of an aliquot of 5 μg/mL of DICNa as a divisor, ROSCa could be determined by measuring 1DD amplitudes at 239.5 and 266.5 nm for ROSCa, while TIM could be similarly determined at 307.7 and 331 nm. DICNa could be determined at 269.7 and 292 nm when 5 μg/mL aliquot of ROSCa was used as a divisor without interference. This method showed limit of detection of 0.556, 0.567 & 0.3 µg/mL and correlation coefficients of 0.9997, 0.9998 and 0.9995 for ROSCa, DICNa and TIM respectively. Method B, depends on subjecting the ratio spectra to mean centering (MCRS). The arithmetical description of this method was explained. The method was performed for the estimation of these drugs together in one run without preseparation in authentic laboratory prepared mixtures, bulk and spiked human plasma. The wave lengths 277.9, 313.1 and 333.12 nm were used for the quantitative estimation of each of the studied drugs with good correlation coefficients (0.9998, 0.997& 0.9999 and LOD of 0.297, 0.150 & 0.24 µg/mL for the studied drugs in the previously mentioned order. Method C, successive-ratio derivative spectra method (SRDS). The mathematical description of the method was explained. By using this method, ROSCa, TIM and DICNa could be determined at 264, 339 and 300 nm, respectively. Correlation coefficients were 0.9998, 0.9999 & 0.9995 and LOD values of 0.374, 0.258 & 0.769 µg/mL in the same order. The three methods were linear in the range 5-25 µg/mL. The obtained results has been statistically compared with those obtained by the published one, showing no significant difference regarding accuracy and precision at p = 0.05. The developed methods do not need sophisticated techniques or instruments, besides being sensitive, selective and eco-friendly.

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Development and Validation of a Complexometric Titration Method for the Determination of Rosuvastatin Calcium in Raw Material

Cited by 6 publications

References 21 publications

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Simultaneous determination of bisoprolol fumarate and rosuvastatin calcium in a new combined formulation by validated RP-HPLC

Novel Spectrophotometric Methods for Simultaneous Determination of Rosuvastatin Calcium, Timolol Maleate and Diclofenac Sodium in Pharmaceutical Ternary Mixture and Spiked Human Plasma

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