Development And Validation Of Uv Spectrophotometric Method For The Determination Of Metformin Hcl, Rosuvastatin Calcium And Telmisartan In Bulk Drug

Research Article
Shreeraj Shah., Kaushika Patel and Darshil Shah
DOI: 
http://dx.doi.org/10.24327/ijrsr.2017.0807.0569
Subject: 
science
KeyWords: 
Anti-diabetic drug, HMG CoA- Reductase Inhibitor, Anti-hypertensive drug; Metformin HCl, Rosuvastatin Calcium, Telmisartan and Validation
Abstract: 

The present manuscript describes UV spectrophotometric method for the simultaneous determination of Metformin HCl, Rosuvastatin calcium and Telmisartan in bulk drug. The various parameters, such as linearity, precision, accuracy, specificity, robustness, limit of detection and limit of quantitation were studied according to (ICH) International Conference on Harmonization guidelines. The first derivative UV spectrophotometric method was performed at 208nm, 233nm and 221nm for Metformin HCl, Rosuvastatin Calcium and Telmisartan respectively in 0.1N HCl solution and distilled water (50:50). The linearity was obtained in the concentration range of 2-10 μg/ml for Metformin and Telmisartan, 10-50 μg/ml for Rosuvastatin Calcium with correlation coefficient (R2 ) 0.994 for Metformin HCl and Rosuvastatin Calcium & 0.998 for Telmisatan. The mean % recoveries were found to be 99.11±0.15, 99.71±0.47 and 98.88±0.66 for Metformin HCl, Rosuvastatin Calcium and Telmisartan respectively. The proposed method is highly sensitive, precise and accurate and therefore can be used for its intended purpose. The suitability of these methods for the quantitative determination of Metformin HCl, Rosuvastatin Calcium and Telmisartan was proved by validation. The proposed method has been validated as per ICH guidelines and successfully applied to the simultaneous estimation of Metformin HCl, Rosuvastatin Calcium and Telmisartan in bulk drug. The results of analysis have been validated statistically and by recovery studies