Development and validation of a method for simultaneous densitometric estimation of atorvastatin calcium and ezetimibe as the bulk drug and in tablet dosage forms

• Autorzy: Dhaneshwar S. S. , Dhaneshwar S. R. , Deshpande P. , Patil M.
• Języki publikacji: EN

Abstrakty

EN

Atorvastatin calcium is a selective HMG-CoA reductase inhibitor and ezetimibe has lipid-lowering activity. Both are potential anti-lipidaemic agents used in combination to reduce the amount of cholesterol and triglycerides in systemic circulation. This paper describes a simple, precise, and accurate HPTLC method for simultaneous quantification of these compounds as the bulk drug and in tablet dosage forms. Chromatographic separation of the drugs was performed on aluminium plates precoated with silica gel 60 F254, with toluene–methanol 8:2 (v/v) as mobile phase. Densitometric evaluation of the separated zones was performed at 240 nm. The two drugs were satisfactorily resolved with RF values 0.23 ± 0.01 and 0.39 ± 0.01 for atorvastatin calcium and ezetimibe, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (0.4–2.4 µg/zone for both atorvastatin calcium and ezetimibe), precision (intra-day RSD 1.16–1.25% and inter-day RSD 1.16–1.44% for atorvastatin calcium, and intra-day RSD 0.47–0.63% and inter-day RSD 0.47–0.88% for ezetimibe), accuracy (98.51 ± 0.23% for atorvastatin calcium and 99.01 ± 0.15% for ezetimibe), and specificity, in accordance with ICH guidelines. The method can be used for analysis of ten or more formulations on a single plate and is a rapid and cost-effective quality-control tool for routine simultaneous analysis of atorvastatin calcium and ezetimibe as the bulk drug and in tablet formulations.

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2007
• Tom: No. 19
• Strony: 141--148
• Opis fizyczny: Bibliogr. 12 poz., rys., tab.

Twórcy

autor

Dhaneshwar S. S.

autor

Dhaneshwar S. R.

autor

Deshpande P.

autor

Patil M.

• Department of Pharmaceutical Chemistry, Poona College of Pharmacy, Bharati Vidyapeeth University, Erandwane, Pune-411 038, India

Bibliografia

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• [10] ICH Guidance on Analytical Method Validation. In: Proc. Int. Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September, 2002
• [11] ICH, Q2A Validation of Analytical Procedures: Methodology International Conference on Harmonization, Geneva, October, 1994
• [12] ICH, Q2B Validation of Analytical Procedures: Methodology International Conference on Harmonization, Geneva, March, 1996