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Validated Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Azelnidipine and Olmesartan in Their Combined Dosage Form.

Patel JK, Patel NK - Sci Pharm (2014)

Bottom Line: The retention times for Azelnidipine and Olmesartan were about 8.56 and 3.04 min, respectively.Calibration curves were linear in the ranges of 2-48 μg/mL for Azelnidipine and 2.5-60 μg/mL for Olmesartan with correlation coefficients >0.990.The proposed method proved to be selective and stability-indicating by the resolution of the two analytes from the forced degradation (hydrolysis, oxidation, and photolysis) products.

View Article: PubMed Central - PubMed

Affiliation: Nootan Pharmacy College, S.P. Sahkar Vidhyadham, Kamana Crossing, Visnagar 384315, Mehsana, Gujarat, India.

ABSTRACT
A simple, rapid, and highly selective RP-HPLC method was developed for the simultaneous determination of Azelnidipine (AZL) and Olmesartan (OLM) drug substances in the fixed dosage strength of 16 mg and 20 mg, respectively. Effective chromatographic separation was achieved using a Hypersil GOLD C18 column (150 mm × 4.6 mm internal diameter, 5 µm particle size) with a mobile phase composed of methanol, acetonitrile, and water in the ratio of 40:40:20 (by volume). The mobile phase was pumped using a gradient HPLC system at a flow rate of 0.5 mL/min, and quantification of the analytes was based on measuring their peak areas at 260 nm. The retention times for Azelnidipine and Olmesartan were about 8.56 and 3.04 min, respectively. The reliability and analytical performance of the proposed HPLC procedure were statistically validated with respect to system suitability, linearity, ranges, precision, accuracy, specificity, robustness, detection, and quantification limits. Calibration curves were linear in the ranges of 2-48 μg/mL for Azelnidipine and 2.5-60 μg/mL for Olmesartan with correlation coefficients >0.990. The proposed method proved to be selective and stability-indicating by the resolution of the two analytes from the forced degradation (hydrolysis, oxidation, and photolysis) products. The validated HPLC method was successfully applied to the analysis of AZL and OLM in their combined dosage form.

No MeSH data available.


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Linearity and range for OLM
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Figure 9: Linearity and range for OLM

Mentions: The calibration curves were plotted over the concentration range of 2–48 µg/ml for Azelnidipine and 2.5–60 µg/ml for Olmesartan. Accurately measured working standard solutions of Azelnidipine (0.2, 0.4, 0.8, 1.6, 3.2, and 4.8 ml) and Olmesartan (0.25, 0.5, 1.0, 2.0, 4.0, and 6.0 ml) were transferred to a series of 10-ml volumetric flasks and the volume in each flask was adjusted to 10 ml with the mobile phase. Resulting solutions were injected into the column and the peak areas obtained at the retention times 3.04 and 8.56 minutes at a flow rate of 0.5 ml/min were measured at 260 nm for Olmesartan and Azelnidipine, respectively. Calibration curves were constructed by plotting peak area versus concentration. Each reading was the average of three determinations (figures 8 and 9). Regression analysis data is shown in Table 4.


Validated Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Azelnidipine and Olmesartan in Their Combined Dosage Form.

Patel JK, Patel NK - Sci Pharm (2014)

Linearity and range for OLM
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4318177&req=5

Figure 9: Linearity and range for OLM
Mentions: The calibration curves were plotted over the concentration range of 2–48 µg/ml for Azelnidipine and 2.5–60 µg/ml for Olmesartan. Accurately measured working standard solutions of Azelnidipine (0.2, 0.4, 0.8, 1.6, 3.2, and 4.8 ml) and Olmesartan (0.25, 0.5, 1.0, 2.0, 4.0, and 6.0 ml) were transferred to a series of 10-ml volumetric flasks and the volume in each flask was adjusted to 10 ml with the mobile phase. Resulting solutions were injected into the column and the peak areas obtained at the retention times 3.04 and 8.56 minutes at a flow rate of 0.5 ml/min were measured at 260 nm for Olmesartan and Azelnidipine, respectively. Calibration curves were constructed by plotting peak area versus concentration. Each reading was the average of three determinations (figures 8 and 9). Regression analysis data is shown in Table 4.

Bottom Line: The retention times for Azelnidipine and Olmesartan were about 8.56 and 3.04 min, respectively.Calibration curves were linear in the ranges of 2-48 μg/mL for Azelnidipine and 2.5-60 μg/mL for Olmesartan with correlation coefficients >0.990.The proposed method proved to be selective and stability-indicating by the resolution of the two analytes from the forced degradation (hydrolysis, oxidation, and photolysis) products.

View Article: PubMed Central - PubMed

Affiliation: Nootan Pharmacy College, S.P. Sahkar Vidhyadham, Kamana Crossing, Visnagar 384315, Mehsana, Gujarat, India.

ABSTRACT
A simple, rapid, and highly selective RP-HPLC method was developed for the simultaneous determination of Azelnidipine (AZL) and Olmesartan (OLM) drug substances in the fixed dosage strength of 16 mg and 20 mg, respectively. Effective chromatographic separation was achieved using a Hypersil GOLD C18 column (150 mm × 4.6 mm internal diameter, 5 µm particle size) with a mobile phase composed of methanol, acetonitrile, and water in the ratio of 40:40:20 (by volume). The mobile phase was pumped using a gradient HPLC system at a flow rate of 0.5 mL/min, and quantification of the analytes was based on measuring their peak areas at 260 nm. The retention times for Azelnidipine and Olmesartan were about 8.56 and 3.04 min, respectively. The reliability and analytical performance of the proposed HPLC procedure were statistically validated with respect to system suitability, linearity, ranges, precision, accuracy, specificity, robustness, detection, and quantification limits. Calibration curves were linear in the ranges of 2-48 μg/mL for Azelnidipine and 2.5-60 μg/mL for Olmesartan with correlation coefficients >0.990. The proposed method proved to be selective and stability-indicating by the resolution of the two analytes from the forced degradation (hydrolysis, oxidation, and photolysis) products. The validated HPLC method was successfully applied to the analysis of AZL and OLM in their combined dosage form.

No MeSH data available.


Related in: MedlinePlus