Determination Of Rosuvastatin Calcium Research Articles

Determination of Rosuvastatin Calcium in bulk and Pharmaceutical dosage forms by using UV-Spectrophotometric method

Determination of Rosuvastatin Calcium in bulk and Pharmaceutical dosage forms by using UV-Spectrophotometric method

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

A reliable, sensitive and stability-indicating reverse phase HPLC method was developed for the determination of Rosuvastatin calcium and its lactone impurity in drug substance and pharmaceutical dosage form. Rosuvastatin calcium was fourth highest selling drug in the United States, accounting approximately $5.2 billion in the year of 2013, which is used for the treatment of hypercholesterolemia. The resolution between Rosuvastatin and lactone impurity was good with resolution factors more than 10.0. The chromatographic separation was achieved on a sunfire column C18 (250 x 4.6 mm, 5 μm) with mobile phase containing a gradient mixture of solvent-A (10 mM ammonium acetate) and solvent-B (acetonitrile: methanol (50: 50 v/v)). The eluted compounds were monitored at 242 nm and the total run time was 15 minutes. Degradation behavior of the Rosuvastatin calcium was studied under various degradation stress conditions. The Limit of detection and limit of quantitation of lactone impurity was found to be 0.01μg/mL and 0.04μg/mL, respectively, for 10μL injection volume. The sample solution and mobile phase were stable for at least 48 hours. The proposed accurate method can be useful for quantification of Rosuvastatin calcium and its lactone impurity in the bulk drug substance and also dosage form.

Development and validation of a stability-indicating RP-LC method for the determination of rosuvastatin calcium and ezetimibe in the presence of their acid degradation products in bulk drug, mixture and pharmaceutical preparations with kinetic study of rosuvastatin and ezetimibe acid degradation

A simple, selective and precise stability-indicating liquid chromatographic method is developed and validated for determination of two antihyperlipidemics; rosuvastatin calcium (RSV) and ezetimibe (EZE) in presence of their acid degradation products. Multiple peaks of degradation products of each drug were well separated from peak of the intact. Besides, when RSV and EZE are in mixture, their peaks are well separated from peaks of degradation products. The method is based on isocratic elution of RSV, EZE and their degradants on a reversed phase C18 column (250mm ⇥ 4mm, 3/mum) – YMC using a mobile phase consisting of methanol–acetonitrile– sodium dihydrogen phosphate (pH=3.2;0.02 M) (10:38:52,v/v/v). Quantitation was achieved with UV detection at 242 nm. Linearity, accuracy and precision were found to be acceptable over concentration range of 0.1–200 /mug mL 1 for both drugs. The proposed method was successfully applied to the determination of cited drugs in bulk and pharmaceutical preparations, and then used to study the kinetics of RSV and EZE acid degradation that was found to follow a first order reaction. The activation energy was estimated from Arrhenius plot and integrated equation, was found to be 8.727 kcal mol 1 and 9.110 kcal mol 1 for RSV and EZE, respectively.

SELECTIVE CHROMATOGRAPHIC METHODS FOR THE DETERMINATION OF ROSUVASTATIN CALCIUM IN THE PRESENCE OF ITS ACID DEGRADATION PRODUCTS

Two accurate and sensitive stability-indicating methods for the determination of rosuvastatin calcium in the presence of its acid degradation products are presented. The first method utilizes quantitative spectrodensitometric evaluation thin-layer chromatography (TLC) of rosuvastatin calcium in the presence of its acid degradation products, using ethyl acetate/methanol/ammonia (7:3:0.01, by volume) as a mobile phase. Chromatograms are scanned at 245 nm. This method analyzes rosuvastatin calcium in a concentration range of 0.6–3.4 µg/band with mean percentage recovery of 99.78 ± 1.42. The second method is a high-performance liquid chromatography (HPLC) method for the simultaneous determination of rosuvastatin calcium in the presence of its acid degradation products. The mobile phase consists of water/acetonitrile/methanol (40:40:20, by volume). The standard curve of rosuvastatin calcium shows a good linearity over a concentration range of 10–60 µg mL−1 with mean percentage recovery of 100.22 ± 0.86. These methods were successfully applied to the determination of rosuvastatin calcium in bulk powder, laboratory-prepared mixtures containing different percentages of the acid degradation products, and pharmaceutical dosage forms. The validity of results was assessed by applying standard addition technique. The results obtained were found to agree statistically with those obtained by a reported method, showing no significant difference with respect to accuracy and precision.

Novel Microwell-Based Spectrophotometric Assay for the Determination of Rosuvastatin Calcium in its Pharmaceutical Formulations

Novel Microwell-Based Spectrophotometric Assay for the Determination of Rosuvastatin Calcium in its Pharmaceutical Formulations

Extractive Spectrophotometric Methods for the Determination of Rosuvastatin Calcium in Pure Form and in Pharmaceutical Formulations by Using Safranin O and Methylene blue

Two simple extractive Spectrophotometric methods are described for the determination of rosuvastatin calcium (RST) in pure form and in pharmaceutical formulations. These methods are based on the formation of ion association complexes of the RST with basic dyes safranin O (Method A) and methylene blue (Method B) in basic buffer of pH 9.8 followed by their extraction in chloroform. The absorbance of the chloroform layer for each method was measured at its appropriate λmax against the reagent blank. These methods have been statistically evaluated and are found to be precise and accurate.

Determination of rosuvastatin calcium in its bulk drug and pharmaceutical preparations by high-performance thin-layer chromatography

A normal-phase TLC method has been established for the estimation of rosuvastatin calcium in its bulk drug and pharmaceutical formulations. Analysis was performed in a Camag twin-trough chamber on silica gel 60F 254 HPTLC plates. Aceclofenac was used as internal standard. The optimized mobile phase was toluene-metha nol-ethyl acetate-formic acid, 6.0 + 1.0 + 3.0 + 0.1 ( v/v ). Quantitation was performed densitometrically at λ = 265 nm. A good correlation coefficient ( r 2 = 0.9999) was obtained for the linearity for amounts of sample in the range 1.0 to 15.0 μg. The assay was performed using methanol as solvent for both the formulation and the bulk drug. For formulation and bulk drug the mean percentage assay was 100.09 ± 0.20 and 100.07 ± 0.48, respectively. The accuracy of the method was found to be 100.62% and precision was found to be vary from 0.01% to 0.77%. The procedure was simple and rapid and the results were reliable.