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Simultaneous quantitation and monitoring of rosuvastatin with NSAIDs by liquid chromatography with UV detection

Authors Arayne MS, Sultana N, Tabassum A

Received 12 July 2012

Accepted for publication 5 September 2012

Published 24 October 2012 Volume 2012:2 Pages 19—29


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Muhammad Saeed Arayne,1 Najma Sultana,2 Arman Tabassum1

1Department of Chemistry; 2Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan

Overview and methods: A simple, accurate, and sensitive high-performance liquid chromatography-ultraviolet detection method was developed for simultaneous determination of rosuvastatin with co-administered nonsteroidal anti-inflammatory drugs (meloxicam, ibuprofen, and mefenamic acid) in active pharmaceutical ingredient (API), pharmaceutical formulations, and human serum. Isocratic separation was employed on prepacked Purospher Star C18 (5 µm, 25 × 0.46 cm) columns at ambient temperature. The mobile phase consisted of methanol:water:acetonitrile (80:17.5:2.5 v/v), pH adjusted to 3.0 with o-phosphoric acid at 1 mL min-1. The drugs in the eluant were monitored at isosbestic point of drugs at 230 nm. The method was compared by programming the detector adjusting the wavelength with time to match the individual analyte's chromophore which enhanced sensitivity with linear range.
Results: Linear behavior was observed between 0.1 and 2.5 µgmL–1 for rosuvastatin, 0.4 and 10 µgmL-1 for meloxicam, 0.25 and 6.25 µgmL-1 for ibuprofen, and 0.15 and 3.75 µgmL-1 for mefenamic acid, with r2 > 0.998. The relative standard deviation for inter-day precision was <2 in API, formulations, and human serum. Percent recovery for all drugs was 97.3%–100.89% in API and formulations and 99.3%–100.4% in human serum. Wavelength-programmed analysis made the method more sensitive, where 4 < limit of quantification (LOQ) < 11 and 1 < limit of detection (LOD) < 4 ngmL-1 for API; 6 < LOQ < 10 and 2 < LOD < 3 ngmL-1 for pharmaceutical formulations; and 3 < LOQ < 10 and 1 < LOD < 3 ngmL-1 in human serum, reduced from 9 < LOQs < 23 and 3 < LODs < 7 ngmL–1 for all drug analytes in API; and 4 < LOQs < 17 and 1 < LODs < 6 ngmL-1 in human serum recorded at isosbestic point for rosuvastatin, meloxicam, ibuprofen, and mefenamic acid, respectively. Recovery of drugs was 99.998%–104.000% in all API, formulations, and serum samples.
Conclusion: The proposed method can be used for the quantitative analysis of these drugs in raw materials, in bulk drugs, dosage formulations and in human serum and for clinical studies even when the drug is present in low amounts.

Keywords: meloxicam, ibuprofen, mefenamic acid, liquid chromatography, quantitative analysis

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