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Sci. Pharm. 2013, 81(1), 93-114; doi:10.3797/scipharm.1208-06

Stress Degradation Behavior of Atorvastatin Calcium and Development of a Suitable Stability-Indicating LC Method for the Determination of Atorvastatin, its Related Impurities, and its Degradation Products

1
Analytical Research, Custom Pharmaceutical Services, Dr. Reddy’s Laboratories Ltd., Bollaram road, Miyapur, Hyderabad-500049 (AP), India
2
Department of Chemistry, Andhra University, Visakhapatnam-530003, India
*
Author to whom correspondence should be addressed.
Received: 13 August 2012 / Accepted: 9 October 2012 / Published: 9 October 2012
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Abstract

A rapid, reversed-phase liquid chromatographic method was developed for the quantitative determination of Atorvastatin calcium, its related substances (12 impurities), and degradation impurities in bulk drugs. The chromatographic separation was achieved on a Zorbax Bonus-RP column by employing a gradient elution with water–acetonitrile–trifluoroacetic acid as the mobile phase in a shorter run time of 25 min. The flow rate was 1.0 mL/min and the detection wavelength was 245 nm. The drug substance was subjected to stress studies such as hydrolysis, oxidation, photolysis, and thermal degradation, and considerable degradation was observed in acidic hydrolysis, oxidative, thermal, and photolytic stress conditions. The formed degradation products were reported and were well-resolved from the Atorvastatin and its related substances. The stressed samples were quantified against a qualified reference standard and the mass balance was found to be close to 99.5% (w/w) when the response of the degradant was considered to be equal to the analyte (i.e. Atorvastatin), which demonstrates the stability-indicating capability of the method. The method was validated in agreement with ICH requirements. The method developed here was single and shorter (25 min method for the determination of all 12 related impurities of Atorvastatin and its degradation products), with clearly better resolution and higher sensitivity than the European (85 min method for the determination of six impurities) and United States pharmacopeia (115 min and 55 min, two different methods for the determination of six related substances).
Keywords: Atorvastatin calcium; RP-HPLC; Stability-indicating method; Forced degradation; LC-MS; Validation Atorvastatin calcium; RP-HPLC; Stability-indicating method; Forced degradation; LC-MS; Validation
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

VUKKUM, P.; BABU, J.M.; MURALIKRISHNA, R. Stress Degradation Behavior of Atorvastatin Calcium and Development of a Suitable Stability-Indicating LC Method for the Determination of Atorvastatin, its Related Impurities, and its Degradation Products. Sci. Pharm. 2013, 81, 93-114.

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