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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

UV overlaid spectra of ATV and AMLUV overlaid spectra of ATV (10 μg/ml) and AML (10 μg/ml).
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Figure 0002: UV overlaid spectra of ATV and AMLUV overlaid spectra of ATV (10 μg/ml) and AML (10 μg/ml).

Mentions: Optimization of mobile phase was performed based on resolution of the drugs and degradation products, asymmetric factor and theoretical plates obtained for AML and ATV. The mobile phase consisting of 0.02 M potassium dihydrogen phosphate: acetonitrile:methanol (30:10:60, v/v/v; pH 4) was selected which gave sharp, well-resolved peaks for AML and ATV (fig. 1). The retention times for AML and ATV were 4.5 and 11.6 min, respectively. The asymmetric factors for AML and ATV were 1.3 and 1.0, respectively. UV overlaid spectra of AML and ATV showed that both the drugs absorbed appreciably at 240 nm, so the same was selected as the detection wavelength during the studies (fig. 2). The calibration curve was found to be linear over the range of 0.1-20 μg/ml for AML and 0.08-20 μg/ml for ATV. The data of regression analysis of the calibration curves are shown in Table 1.


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)

UV overlaid spectra of ATV and AMLUV overlaid spectra of ATV (10 μg/ml) and AML (10 μg/ml).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 0002: UV overlaid spectra of ATV and AMLUV overlaid spectra of ATV (10 μg/ml) and AML (10 μg/ml).
Mentions: Optimization of mobile phase was performed based on resolution of the drugs and degradation products, asymmetric factor and theoretical plates obtained for AML and ATV. The mobile phase consisting of 0.02 M potassium dihydrogen phosphate: acetonitrile:methanol (30:10:60, v/v/v; pH 4) was selected which gave sharp, well-resolved peaks for AML and ATV (fig. 1). The retention times for AML and ATV were 4.5 and 11.6 min, respectively. The asymmetric factors for AML and ATV were 1.3 and 1.0, respectively. UV overlaid spectra of AML and ATV showed that both the drugs absorbed appreciably at 240 nm, so the same was selected as the detection wavelength during the studies (fig. 2). The calibration curve was found to be linear over the range of 0.1-20 μg/ml for AML and 0.08-20 μg/ml for ATV. The data of regression analysis of the calibration curves are shown in Table 1.

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