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HPLC Method Development and Validation for the Simultaneous Estimation of Atorvastatin Calcium and Sildenafil
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| Author:
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SHAIKH RIZWAN N, DR SUFIYAN AHMAD, DR SHAIKH SIRAJ NAWAJ
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| Abstract:
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The aim & objectives of this research work was to develop a simple, selective, linear, precise, and accurate HPLC method for simultaneous estimation of Atorvastatin Calcium and Sildenafil in pure form. Chromatographic separation was performed with low pressure gradient using C18 column (250 X 4.6 mm, 5µ particle size)..Mobile phase composed 0.05M Phosphate buffer pH-4 and Acetonitrile (30:70 v/v) at a flow rate of 1 ml/min. Detection was carried out using UV detector at 272 nm. The method was validated as per ICH guidelines. The Retention time for Atorvastatin Calcium and Sildenafil are observed as 3.34 and 3.92 minutes respectively. Linearity range was observed in concentration of 1-10µg/ml for both the drugs. The percentage recoveries of Atorvastatin Calcium and Sildenafil are 101.90% and 103.42% respectively. The correlation coefficients for both the components are close to 1. The results were found to be precise due to low values of the %RSD. It indicated that the method has good precision. LOQ for Sildenafil & for Atorvastatin Calcium were 0.046µg/ml and 0.044µg/ml and similarly LOD for both Sildenafil & for Atorvastatin Calcium was found to be 0.015µg/ml and 0.014µg/ml. Robustness & Ruggedness studies proved that the developed methods were found to be robust & rugged on deliberate changes done. A Simple, sensitive, accurate, precise HPLC method was developed and validated for the simultaneous estimation of Atorvastatin Calcium & Sildenafil. This developed method can be successfully employed for the routine quality control of dosage forms containing both the drugs in Pharmaceutical industries.
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| Keyword:
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HPLC, Method development, Validation, Accuracy, Atorvastatin Calcium, Sildenafil.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.715
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