Analytical Method Development and Validation for the Estimation of Rosuvastatin Calcium in Raw Material and Tablet Formulation by UV Spectrometric Method
Journal Title: Saudi Journal of Medical and Pharmaceutical Sciences - Year 2016, Vol 2, Issue 1
Abstract
Abstract: Statins are the treatment of choice for controlling hypercholesterolemia in patients with cardiovascular risk. Although all statins are HMG-CoA reductase inhibitors, they possess different chemical structure, pharmacokinetic profile and lipid modifying efficacy. From the published literature, it is known that Rosuvastatin calcium is more effective in lowering bad cholesterol and raising good cholesterol compared to rest of statins. Extensive analytical methods for the determination of Rosuvastatin are more complex, expensive and time-consuming. So the present study is focused on development and validation of a reliable, simple and economic method for the estimation of Rosuvastatin Calcium in bulk and formulation. Analytical method development being a vital part of pre-formulation and formulation, research and development obviates the need to develop reliable and economical methods for the estimation of drugs in bulk and formulation. UV Spectroscopy is one of the earliest and widely used methods in drug analysis despite the availability of chromatographic and hyphenated techniques. A simple, precise, sensitive, accurate and economical method has been developed for the estimation of Rosuvastatin Calcium in bulk and formulation. The drug exhibits an absorption maximum at a wavelength of 240nm with 0.1N sodium hydroxide as solvent. Beer’s law is obeyed in the concentration range of 1-6µg/ml and percentage purity is found to be 98.90%. LOD and LOQ values are found to be 0.603 and 0.830µg/ml. The developed method is validated statistically as per ICH guidelines and the results obtained are within acceptance criteria related to linearity, accuracy and precision. Keywords: Rosuvastatin Calcium, Sodium Hydroxide, Hypercholesterolemia, Accuracy, Precision.
Authors and Affiliations
B. Sailaja, K. Sravana Kumari
Keywords
Related Articles
- EP ID EP388268
- DOI -
- Views 190
- Downloads 0
Clinical Profile of Deliberate Self Poisoning in Eastern Part of the Sri Lanka
Abstract:The rate of non-fatal deliberate self-harm (DSH) in Sri Lanka has increased in recent years, with associated morbidity and economic cost to the country. Pesticide ingestion is the commonest mode of suicide in As...
Urinary Schistosomiasis among School Pupils in Ilie Community, Southwestern Nigeria
Abstract: Urinary schistosomiasis though a neglected disease is endemic in many rural communities in Nigeria and is second only to malaria. The present study was carried out to determine the current status of urinary sch...
Prostate Cancer: Insights of Current Treatment, Prevention and Management
Abstract:The prostate is an exocrine gland of the male reproductive system, and exists directly under the bladder, in front of the rectum with approximately the size of a walnut. Male hormones affect the growth of the pr...
Determination of Antibiotic Sensitivity Pattern Along With Isolation of Helicobacter Pylori from Gastric Mucosa in North West Region of Rajasthan
Abstract:The Importance ofH. pylorias an etiological agent in gastroduodenal disease had suggested antibiotictreatment as a main target for the elimination of infection and to determine the prevalence of Helicobacter pyl...
Development and Validation of Various UV Spectrophotometric Methods for the Estimation of Famciclovir in Bulk and its Formulation
Abstract:The present paper described about the development and validation of three different simple, sensitive, rapid, accurate and economical UV Spectrophotometric methods. The developed methods were used for the quanti...