Rp-HPLC Method Development and Validation for Simultaneous Estimation of Cilnidipine and Telmisartan in Combined Pharmaceutical Dosage Form

Khandagale, Pravin Y; Bhajipale, Nitin S; Badkhal, Amol V

doi:10.7897/2230-8407.089166

Int. Res. J. Pharm.

2017

DOI: 10.7897/2230-8407.089166

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Rp-HPLC Method Development and Validation for Simultaneous Estimation of Cilnidipine and Telmisartan in Combined Pharmaceutical Dosage Form

Pravin Y Khandagale¹,

Nitin S Bhajipale²,

Amol V Badkhal³

Abstract: A specific, accurate, precise and reproducible RP-HPLC method development validation for simultaneous estimation of cilnidipine and telmisartan in combined pharmaceutical dosage form. The proposed HPLC method utilizes Youglin C18 column (250 mm x 4.6 mm) 5 µm particle sizes and mobile phase consisting of Acetonitrile: 0.05% ortho phosphoric acid (60: 40) at a flow rate of 0.7 ml/min with UV detection 236 nm. The retention time of cilnidipine and telmisartan were found to be 4.650 min and 8.050 min respectively… Show more

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A review on analytical methods of cilnidipine and its combinations

Mishra

Mehta

2022

EJPPS

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Background - The chase to improve the quality of life has stimulated desirable changes in research to design and develop a new drug and enhance its safety and effectiveness. Thus, there is a gradual rise in demand to develop susceptible and specific analytical techniques for newly developed drugs. Thus, analysts are striving very hard to develop new and efficient analytical methods to achieve these targets. Main body of abstract - Analytical methods that analyze drug compounds in a given matrix need to be optimized and validated to ensure excellent selectivity, sensitivity, ease of use, speed of analysis, less expensive, and efficient analytical procedures. Developing a new analytical method should be considered critical, based on availability and accurate handling of different instruments. This review is a genuine venture of compiled literature of earlier and recent trends in the method developments for Cilnidipine (CLD) analysis alone and in combination with other drugs. It provides an in-depth assortment of practical aspects of various analytical techniques published for CLD. Conclusion - High-performance liquid chromatography and ultraviolet spectroscopy have been found the most acceptable for the analysis of CLD. Stability indicating studies and impurity profiling of CLD also prevailed in the assembled literature. Scanty work was observed with capillary electrophoresis, Fourier transform-infrared spectroscopy, and electroanalytical methods to analyze CLD. Applications mentioned for CLD are significant in their particular field and contribute to analytical assay in future endeavours. Keywords- Cilnidipine, Bioanalytical method, Stability indicating method, HPLC, Spectrophotometry.

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A review on analytical methods of cilnidipine and its combinations

Mishra

Mehta

2022

EJPPS

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Stability-Indicating Reversed-Phase HPLC Method for the Separation and Estimation of Related Impurities of Cilnidipine in Pharmaceutical Formulations

Bikshal¹,

Rao²,

Reddy³

2018

IND. DRU.

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A novel HPLC method was developed and validated for the determination of cilnidipine (CLDP) along with its related impurities A and B in pharmaceutical formulations. The chromatographic separation was carried out by isocratic elution using an X Terra C18 column (250×4.6mm; 5μ). The mobile phase was composed of methanol and phosphate buffer at a pH of 5.8 in the ratio of 10:90 (V/V) at a flow rate of 1.0 mL/min. The eluents were detected and quantified at a UV detection wavelength of 229 nm. Calibration curves of all analytes in the range of 2-12μg/mL showed a good correlation linearly (r ≥ 0.999) with recovery rate of more than 98% for each analyte. The percentage RSD in intraday, interday precision and ruggedness were found to be less than 2. Small variations in the developed conditions like mobile phase ratio, flow rate, pH and UV wavelength do not influence the results. This proves the precise and robust nature of the developed method. Stress degradation studies were conducted for standard drug and high amount of degradation was observed under UV light exposure. After 24hours, the molecules degraded up to 9.967%. In base hydrolysis, the CLDP molecule degrades up to 6.223%. In other stress conditions like acidic (5.347%), oxidative (4.916%) and thermal (4.319%) conditions, CLDP was found to be highly labile. In stress degradation study, there is no interference of both known impurities and other degradation products formed and were separated from CLDP. Therefore, this method was found to be selective and specific. The method development and validation result confirms that this method is suitable for determination and quantification of process impurities (A and B) of CLDP in pharmaceutical formulations. Key

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Rp-HPLC Method Development and Validation for Simultaneous Estimation of Cilnidipine and Telmisartan in Combined Pharmaceutical Dosage Form

Cited by 2 publications

References 0 publications

A review on analytical methods of cilnidipine and its combinations

A review on analytical methods of cilnidipine and its combinations

Stability-Indicating Reversed-Phase HPLC Method for the Separation and Estimation of Related Impurities of Cilnidipine in Pharmaceutical Formulations

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