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Stability Indicating RP-HPLC Estimation of Atorvastatin Calcium and Amlodipine Besylate in Pharmaceutical Formulations.

Shah DA, Bhatt KK, Mehta RS, Baldania SL, Gandhi TR - Indian J Pharm Sci (2008)

Bottom Line: The retention times of atorvastatin calcium and amlodipine besylate were 11.6 min and 4.5 min, respectively.The calibration curves were linear in the concentration range of 0.08-20 μg/ml for atorvastatin calcium and 0.1-20 μg/ml for amlodipine besylate.Atorvastatin calcium and amlodipine besylate stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation and dry heat degradation.

View Article: PubMed Central - PubMed

Affiliation: Indukaka Ipcowala College of Pharmacy, P. B. No. 53, Vitthal Udyognagar-388 121, India.

ABSTRACT
A simple, specific, accurate and stability indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of atorvastatin calcium and amlodipine besylate in tablet dosage forms. A phenomenex Gemini C-18, 5 μm column having 250×4.6 mm i.d. in isocratic mode, with mobile phase containing 0.02 M potassium dihydrogen phosphate:acetonitrile:methanol (30:10:60, v/v/v) adjusted to pH 4 using ortho phosphoric acid was used. The flow rate was 1.0 ml/min and effluents were monitored at 240 nm. The retention times of atorvastatin calcium and amlodipine besylate were 11.6 min and 4.5 min, respectively. The calibration curves were linear in the concentration range of 0.08-20 μg/ml for atorvastatin calcium and 0.1-20 μg/ml for amlodipine besylate. Atorvastatin calcium and amlodipine besylate stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation and dry heat degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. The proposed method was validated and successfully applied to the estimation of atorvastatin calcium and amlodipine besylate in combined tablet dosage forms.

No MeSH data available.


Related in: MedlinePlus

Chromatogram of dry heat degradation study of both the drugsChromatogram of dry heat degradation study of ATV (10 μg/ml) and AML (10 μg/ml) at 80° for 2 h
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Figure 0006: Chromatogram of dry heat degradation study of both the drugsChromatogram of dry heat degradation study of ATV (10 μg/ml) and AML (10 μg/ml) at 80° for 2 h

Mentions: Forced degradation study was carried out by subjecting both the drugs to acid and alkali hydrolysis, chemical oxidation and dry heat degradation conditions. The chromatograms of base degraded sample showed degradation product peaks at retention time (RT) 2.95, 3.11 and 3.86 min for AML and ATV was found to be stable to base degradation (fig. 3). The peaks of the degradation products were well resolved from the drug peaks. Acid hydrolysis study showed that AML was stable in acidic condition but ATV gave degradation product peaks at RT 12.63 and 15.92 min (fig. 4). Oxidative stress degradation resulted in degradation product peaks at RT 12.85 and 13.68 min for ATV and AML was indicated to be stable (fig. 5). Dry heat degradation study resulted in to degradation product peaks at 3.06 and 3.37 min for AML and ATV was found to be stable (fig. 6).


Stability Indicating RP-HPLC Estimation of Atorvastatin Calcium and Amlodipine Besylate in Pharmaceutical Formulations.

Shah DA, Bhatt KK, Mehta RS, Baldania SL, Gandhi TR - Indian J Pharm Sci (2008)

Chromatogram of dry heat degradation study of both the drugsChromatogram of dry heat degradation study of ATV (10 μg/ml) and AML (10 μg/ml) at 80° for 2 h
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3040869&req=5

Figure 0006: Chromatogram of dry heat degradation study of both the drugsChromatogram of dry heat degradation study of ATV (10 μg/ml) and AML (10 μg/ml) at 80° for 2 h
Mentions: Forced degradation study was carried out by subjecting both the drugs to acid and alkali hydrolysis, chemical oxidation and dry heat degradation conditions. The chromatograms of base degraded sample showed degradation product peaks at retention time (RT) 2.95, 3.11 and 3.86 min for AML and ATV was found to be stable to base degradation (fig. 3). The peaks of the degradation products were well resolved from the drug peaks. Acid hydrolysis study showed that AML was stable in acidic condition but ATV gave degradation product peaks at RT 12.63 and 15.92 min (fig. 4). Oxidative stress degradation resulted in degradation product peaks at RT 12.85 and 13.68 min for ATV and AML was indicated to be stable (fig. 5). Dry heat degradation study resulted in to degradation product peaks at 3.06 and 3.37 min for AML and ATV was found to be stable (fig. 6).

Bottom Line: The retention times of atorvastatin calcium and amlodipine besylate were 11.6 min and 4.5 min, respectively.The calibration curves were linear in the concentration range of 0.08-20 μg/ml for atorvastatin calcium and 0.1-20 μg/ml for amlodipine besylate.Atorvastatin calcium and amlodipine besylate stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation and dry heat degradation.

View Article: PubMed Central - PubMed

Affiliation: Indukaka Ipcowala College of Pharmacy, P. B. No. 53, Vitthal Udyognagar-388 121, India.

ABSTRACT
A simple, specific, accurate and stability indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of atorvastatin calcium and amlodipine besylate in tablet dosage forms. A phenomenex Gemini C-18, 5 μm column having 250×4.6 mm i.d. in isocratic mode, with mobile phase containing 0.02 M potassium dihydrogen phosphate:acetonitrile:methanol (30:10:60, v/v/v) adjusted to pH 4 using ortho phosphoric acid was used. The flow rate was 1.0 ml/min and effluents were monitored at 240 nm. The retention times of atorvastatin calcium and amlodipine besylate were 11.6 min and 4.5 min, respectively. The calibration curves were linear in the concentration range of 0.08-20 μg/ml for atorvastatin calcium and 0.1-20 μg/ml for amlodipine besylate. Atorvastatin calcium and amlodipine besylate stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation and dry heat degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. The proposed method was validated and successfully applied to the estimation of atorvastatin calcium and amlodipine besylate in combined tablet dosage forms.

No MeSH data available.


Related in: MedlinePlus