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A New Improved RP-HPLC Method for Assay of Rosuvastatin Calcium in Tablets.

Kaila HO, Ambasana MA, Thakkar RS, Saravaia HT, Shah AK - Indian J Pharm Sci (2010)

Bottom Line: Response was a linear function of drug concentration in the range of 0.5-80 μg/ml (r(2)= 0.9993) with a limit of detection and quantification of 0.1 and 0.5 μg/ml respectively.Accuracy (recovery) was between 99.6 and 101.7%.Degradation products resulting from the stress studies did not interfere with the detection of rosuvastatin and the assay is thus stability-indicating.

View Article: PubMed Central - PubMed

Affiliation: National Facility for Drug Discovery through New Chemical Entities Development and Instrumentation Support to Small Manufacturing Pharma Enterprises, Department of Chemistry, Saurashtra University, Rajkot-360 005, India.

ABSTRACT
A reliable and sensitive isocratic stability indicating RP-HPLC method has been developed and validated for assay of rosuvastatin calcium in tablets and for determination of content uniformity. An isocratic separation of rosuvastatin calcium was achieved on YMC C8, 150×4.6 mm i.d., 5 μm particle size columns with a flow rate of 1.5 ml/min and using a photodiode array detector to monitor the eluate at 242 nm. The mobile phase consisted of acetonitrile: water (40:60, v/v) pH 3.5 adjusted with phosphoric acid. The drug was subjected to oxidation, hydrolysis, photolysis and thermal degradation. All degradation products in an overall analytical run time of approximately 10 min with the parent compound rosuvastatin eluting at approximately 5.2 min. Response was a linear function of drug concentration in the range of 0.5-80 μg/ml (r(2)= 0.9993) with a limit of detection and quantification of 0.1 and 0.5 μg/ml respectively. Accuracy (recovery) was between 99.6 and 101.7%. Degradation products resulting from the stress studies did not interfere with the detection of rosuvastatin and the assay is thus stability-indicating.

No MeSH data available.


Related in: MedlinePlus

Structure of rosuvastatin calcium
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Figure 1: Structure of rosuvastatin calcium

Mentions: Rosuvastatin calcium is chemically, bis[(E)-7[4-(4-fluorophenyl)-6-isopropyl-2-[methyl (methyl-sulphonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt (fig. 1). It belongs to a class of drugs called statins, which are employed to lower hypercholesterolemia and related conditions and to prevent cardiovascular diseases. It increases the number of hepatic low density lipoprotein receptors involved in the catabolism of LDL and also inhibits hepatic synthesis of very low density lipoprotein[1–3].


A New Improved RP-HPLC Method for Assay of Rosuvastatin Calcium in Tablets.

Kaila HO, Ambasana MA, Thakkar RS, Saravaia HT, Shah AK - Indian J Pharm Sci (2010)

Structure of rosuvastatin calcium
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3116304&req=5

Figure 1: Structure of rosuvastatin calcium
Mentions: Rosuvastatin calcium is chemically, bis[(E)-7[4-(4-fluorophenyl)-6-isopropyl-2-[methyl (methyl-sulphonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt (fig. 1). It belongs to a class of drugs called statins, which are employed to lower hypercholesterolemia and related conditions and to prevent cardiovascular diseases. It increases the number of hepatic low density lipoprotein receptors involved in the catabolism of LDL and also inhibits hepatic synthesis of very low density lipoprotein[1–3].

Bottom Line: Response was a linear function of drug concentration in the range of 0.5-80 μg/ml (r(2)= 0.9993) with a limit of detection and quantification of 0.1 and 0.5 μg/ml respectively.Accuracy (recovery) was between 99.6 and 101.7%.Degradation products resulting from the stress studies did not interfere with the detection of rosuvastatin and the assay is thus stability-indicating.

View Article: PubMed Central - PubMed

Affiliation: National Facility for Drug Discovery through New Chemical Entities Development and Instrumentation Support to Small Manufacturing Pharma Enterprises, Department of Chemistry, Saurashtra University, Rajkot-360 005, India.

ABSTRACT
A reliable and sensitive isocratic stability indicating RP-HPLC method has been developed and validated for assay of rosuvastatin calcium in tablets and for determination of content uniformity. An isocratic separation of rosuvastatin calcium was achieved on YMC C8, 150×4.6 mm i.d., 5 μm particle size columns with a flow rate of 1.5 ml/min and using a photodiode array detector to monitor the eluate at 242 nm. The mobile phase consisted of acetonitrile: water (40:60, v/v) pH 3.5 adjusted with phosphoric acid. The drug was subjected to oxidation, hydrolysis, photolysis and thermal degradation. All degradation products in an overall analytical run time of approximately 10 min with the parent compound rosuvastatin eluting at approximately 5.2 min. Response was a linear function of drug concentration in the range of 0.5-80 μg/ml (r(2)= 0.9993) with a limit of detection and quantification of 0.1 and 0.5 μg/ml respectively. Accuracy (recovery) was between 99.6 and 101.7%. Degradation products resulting from the stress studies did not interfere with the detection of rosuvastatin and the assay is thus stability-indicating.

No MeSH data available.


Related in: MedlinePlus