Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Cilnidipine
Cilnidipine is one of the dihydropyridine calcium antagonists. It was created combinedly by Fuji Viscera Pharmaceutical Company, Ajinomoto and Japan and was approved in the year 1995. Cilnidipine acts on N-type calcium channel where exist the end of sympathetic nerve in addition to common L-type calcium channel like that of other calcium antagonists. China, Japan, India, Korea and several other countries approved this drug. The objective of the method validation is to demonstrate whether the method was suited for the intended purpose. The method was validated as per the ICH guidelines. The method was validated for linearity, precision (repeatability, intermediate precision), accuracy, specificity, robustness, limit of detection and limit of quantification. Cosmosil (4.6 X 250mm, 5 μ) column was used for separation. The selected wavelength for Cilnidipine was 241 nm. The mobile phase consists Methanol: Potassium dihydrogen phosphate buffer (50:50). Flow rate was delivered at 1.0 mL/min. Appropriate dilutions of standard stock solutions were prepared as per the get desired concentrations in the range of 100-500 mcg/ml. The RT obtained was 4.8165 minutes.
Keywords: Cilnidipine, UV spectroscopy, RP-HPLC, ICH
2. Kudumula, N.; Prasad Rajendra, Y. Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Chlorthalidone and Cilnidipine in Bulk and Combined Tablet Dosage Form. Pharmacophore 2014, 5 (4), 442–450.
3. Mital, J. S.; Patel, B.; Biosci, A. P.-I. J. P.; 2014, U. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Cilnidipine and Olmesartan Medoxomil in Their Combined Tablet Dosage Form. Int. J. Pharm. Biol. Sci. 2014, 4 (1), 157–160.
4. Rupareliya, R.; Joshi, H. Stability Indicating Simultaneous Validation of Telmisartan and Cilnidipine with Forced Degradation Behavior Study by RP-HPLC in Tablet Dosage Form. ISRN Chromatogr. 2013, 1–6.
5. Safhi, M.; Nagaraj, M. Development and Validation of a Rapid Stability Indicating Chromatographic Determination of Cilnidipine in Bulk and Dosage Form. Res. J. Pharm. Tech. 2013, 6 (3), 296–299.
6. Wankhede, S. B.; Bhole, R. p. Development and Validation of HPTLC Method for Simultaneous Estimation Of Cilnidipine And Valsartan In Bulk And Tablet Dosage Form. Int. J. Pharm. Chem. Anal. 2015, 2 (1), 102–107.
7. Patel, P. R.; Patel, N.; Shah, S. K. Analytical Method Development and Validation for Simultaneous Estimation of Nebivolol Hydrochloride and Cilnidipine in Combined Dosage Form. J. Chem. Pharm. Res. 2015, 7 (9), 951–960.
8. Ravi Sankar, P.; Swathi, V. Development and Validation Of Novel UV And RP-HPLC Methods For Determination Of Cilnidipine (A New Generation Ca Channel Blocker) In Pharmaceutical Dosage Form. Int. J. Pharm. Sci. Res. 2019, 10 (4), 1886–1894. https://doi.org/10.13040/IJPSR.0975-8232.10(4).1886-94.
9. Patel, B.; Chaudhary, A. Development and Validation of Reversed Phase High Performance Liquid Chromatography Method for Simultaneous Estimation of Nebivolol HCl and Cilnidipine In. Pharm. Biol. Eval. 2016, 3 (2), 208–214.
10. Dagariya, R.; Jat, R. Method Development and Validation of Irbesartan Chlorthalidone and Cilnidipine in Their Combined Tablet Dosage Form by High Performance Liquid Chromatography. J. Drug Deliv. Ther. 2017, 7 (4), 88–96.
11. Soni, I.; Panchal, H. Development and Validation of Dual Wavelength UV Spectrophotometric Method for Simultaneous Estimation of Cilnidipine and Olmesartan Medoxomil In. Indian J. Pharm. Biol. Res. 2014, 2 (1), 76–81.
12. Patel, S.; Hinge, M.; Bhanushali, V. Development and Validation of an UV Spectrophotometric Method for Simultaneous Determination of Cilnidipine and Chlorthalidone. J. Pharm. Res. 2015, 9 (1), 41–45.
13. Kachave, R.; Kale, M.; Wagh, R. Simultaneous Estimation of Cilnidipine and Valsartan by RP-HPLC in Tablet Formulation. Eurasian J. Anal. Chem. 2016, 11 (5), 245–253.
14. Desai, D.; Vashi, N.; Dalvadi, H. HPTLC Method Development and Validation of Cilnidipine and Metoprolol Succinate in Combined Dosage Form. Pharma methods 2016, 7 (1), 28–34.
15. Haripriya, M.; Antony, N.; Jayasekhar, P. Development and Validation of UV Spectrophotometric Method for the Simultaneous Estimation of Cilnidipine and Telmisartan in Tablet Dosage Form Utilising. Int. J. Pharm. Biol. Sci. 2013, 3 (1), 343–348.
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