SPECTROPHOTOMETRIC ESTIMATION OF CILNIDIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM USING N-(1-NAPHTHYL) ETHYLENE DIAMINE DIHYDROCHLORIDE
Objective: To develop a new, simple and sensitive visible spectrophotometric method for the estimation of Cilnidipine [CIL] in bulk and tablet dosage forms.
Methods: The visible spectrophotometric method was based on the color reaction of CIL with N-(1-Naphthyl) ethylene diamine dihydrochloride reagent [it is stable for 20 min] to form a purple coloured chromophore that has an absorption maxima at 554 nm. The method was validated as per ICH guidelines.
Results: Beer's law was obeyed over the concentration range of 16-24 Î¼g/mL for Cilnidipine. Limit of detection [LOD] and limit of quantification [LOQ] are 0.4365 and 1.3228 respectively. The average recovery was found to be 100.43% w/w.
Conclusion: The method developed is precise, linear and accurate. Satisfactory results were obtained from validation of the method. Hence the proposed method is suitable in quality control of estimation Cilnidipine bulk and pharmaceutical dosage forms.
2. http: //www.chemicalbook.com/ChemicalProductProperty_EN_CB2193117. htm.
3. Mohammed M. Safhi, Spectrophotometric method for the estimation of cilnidipine in bulk and pharmaceutical dosage forms. Orient J Chem 2013;29(1):131â€“4.
4. Pankaj P Chaudhari, AV Bhalerao. Method Validation for Spectrophotometric Estimation of Cilnidipine. Int J Pharm Pharm Sci 2013;4(5):96â€“8.
5. Parihar YP, Kotkar TA, Mahajan MP, Sawant SD. Development and validation of UV Spectrophotometric methods for the simultaneous estimation of Cilnidipine and Telmisartan in tablet and bulk dosage form by Simultaneous Equation and Absorbance Ratio method. Int J Pharm Integrated Life Sci 2014;2(3):59â€“74.
6. M Haripriya, Neethu Antony, P Jayasekhar. Development and validation of UV Spectrophotometric Method for the simultaneous estimation of Cilnidipine and Telmisartan in Tablet Dosage Form utilising Simultaneous Equation and Absorbance Ratio Method. Int J Pharm Biol Sci 2013;3(1):343â€“8.
7. Nilam K Patel, Jayvadan K Patel. Simultaneous UV Spectrophotometric methods for estimation of Cilnidipine and Telmisartan in Tablet Dosage Form. Inventi Rapid: Pharm Analysis & Quality Assurance, 2013. Available from http: //www.inventi.in/Article/ppaqa/576/12.aspx.
8. Isha J Soni, Hiral J Panchal. Development and validation of dual wavelength UV Spectrophotometric Method for simultaneous estimation of Cilnidipine and Olmesartan Medoxomil in Tablet dosage form. Indian J Pharm Biol Res 2014;2(1):76-81.
9. Shahin Vahora, Falgun Mehta, Usmangani Chhalotiya, Dimal Shah. Dual wavelength spectrophotometric method for estimation of cilnidipine and telmisartan in their combined dosage form. Res Rev: J Pharm Anal 2014;3(2):22â€“9.
10. Faimida Jahan, Avnish Jain, Sumeet Prachand, Arun Kumar Gupta. Simultaneous estimation of telmisartan and cilnidipine in solid dosage form. Int J Pharm Res Sci 2012;1(1):32â€“42.
11. Mohammed Safhi M, Nagaraj Manohara Yagaina. Development and validation of a rapid stability indicating chromatographic determination of cilnidipine in bulk and dosage form. Res J Pharm Technol 2013;6(3):296â€“9.
12. Xianhua Zhang, Suodi Zhai, Rongsheng Zhao, Jin Ouyang, Xiaoguang Li, Willy RG Baeyens. Determination of Cilnidipine, a new Calcium antagonist, in human plasma using high performance liquid chromatography with tandem mass spectrometric detection. Anal Chim Acta 2007;1(2):142â€“6.
13. HE Ling-yun, HU Gao-yun, ZHOU Yan-bin, LIU Jian-hao. Determination of Cilnidipine and its related substances by RP-HPLC. West China J Pharm Sci 2004;01.
14. Sidhdhapara Mital. 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):157â€“60.
15. Prajakta Pawar, Santosh V Gandhi, Padmanabh B Deshpande, Suvarna Vanjari, Swapnil U Shelar. Simultaneous RP-HPLC estimation of Cilnidipine and Telmisartan in combined tablet dosage form. Chem Sin 2013;4(2):6â€“10.
16. Reema H Rupareliya, Hitendra S Joshi. Stability indicating simultaneous validation of telmisartan and cilnidipine with forced degradation behavior study by RP-HPLC in tablet dosage form. ISRN Chromatogr; 2013. http: //dx.doi.org/ 10.1155/ 2013/461461.
17. Pawar Prajakta, Deshpande Padmanabh, Gandhi Santhosh, Bhavnani Vandana. high performance thin layer chromatographic determination of cilnidipine and telmisartan in combined tablet dosage form. Int Res J Pharm 2012;3(6):219â€“22.
18. International Conference on Harmonization Guidance for Industry, In: Q2A Text on Validation o f Analytical Methods, Switzerland, IFPMIA 1994:1â€“4.
19. International Conference on Harmonization Guidance for Industry, In: Q2B Text on Validation of Analytical Methods, Switzerland, IFPMI A 1996:1â€“8.