DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF CETIRIZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE IN TABLETS
Abstract
Without resolving mixtures of Cetirizine hydrochloride and Phenylephrine hydrochloride, simultaneous estimation has been successfully achieved by spectrophotometry. First method, simultaneous equation method employs formation and solving of mathematical simultaneous equation using 237.5 nm and 232.0 nm as the λmax of Phenylephrine hydrochloride and Cetirizine hydrochloride respectively in distilled water. Second method is first order derivative spectroscopy, wavelengths selected for quantitation were 232.0 nm for Phenylephrine hydrochloride (zero cross for Cetirizine hydrochloride) and 242.5 nm for Cetirizine hydrochloride (zero cross for Phenylephrine hydrochloride). These methods were validated as per ICH norms. Calibration curves were linear over the concentration ranges of 12-60 μg/ml for both drugs and for both methods. The validation study is statistically significant as all the statistical parameters are within the acceptance range (% RSD < 2.0 and S.D. < 2.0) for both accuracy and precision. The methods are successfully applied to pharmaceutical formulation, with no interference from excipients as indicated by the recovery study. The proposed methods are simple, rapid, economic and accurate for routine simultaneous estimation of Phenylephrine hydrochloride and Cetirizine hydrochloride. Simultaneous equation method was successfully applied to carry out dissolution study of commercial tablet formulation by using USP II dissolution test apparatus.
Keywords:
Phenylephrine hydrochloride, Cetirizine hydrochloride, simultaneous estimation, spectrophotometryDOI
https://doi.org/10.25004/IJPSDR.2012.040311References
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4. Drozd J, Hopkala H, Misztal G, Paw B. Applications of derivative UV- spectrophotometry for the determination of Cetirizine dihydrochloride in preparations. Acta Poloniae Pharmaceutica- Drug Research 2002; 59(1): 3-7.
5. El Walily AFM, Korany MA, El Gindy A, Bedair MF. Spectrophotometric and high performance liquid chromatographic determination of Cetirizine dihydrochloride in pharmaceutical tablets. Journal of Pharmaceutical and Biomedical Analysis 1998; 17: 435-442.
6. Maithani M, Raturi R, Gautam V, Kumar D, Chaudhary AK, Gaurav A, Singh R. Development and validation of a RP-HPLC method for the determination of Chlorpheniramine maleate and Phenylephrine in pharmaceutical dosage form. Pharmacie Globale International Journal of Comprehensive Pharmacy 2010; 5: 5.
7. Wagh RS, Hajare RA, Tated AG, Gadbail PA, Khan FA, Kayal SD. Method development and validation for simultaneous determination of Ebastine and Phenylephrine hydrochloride in tablet formulation by RP-HPLC. International Journal of Pharmaceutical Research and Development 2011; 3(7): 214-220.
8. Demiralay E, Mehmet G, Canbay H. Validation of method for simultaneous determination of Paracetamol and Phenylephrine in pharmaceutical formulation by reversed phase liquid chromatography. Pharmacie Globale International Journal of Comprehensive Pharmacy 2011; 09: 6.
9. Pirol O, Sukuroglu M, Ozden T. Simultaneous determination of Paracetamol, Phenylephrine hydrochloride, Oxolamine citrate and Chlorpheniramine maleate by HPLC in pharmaceutical dosage forms. E-Journal of Chemistry 2011; 8(3): 1275-1279.
10. Maithani M, Raturi R, Gautam V, Kumar D, Gaurav A, Singh R. Simultaneous estimation of Ambroxol hydrochloride and Cetirizine hydrochloride in tablet dosage form by RP-HPLC method. Pharmacie Globale International Journal of Comprehensive Pharmacy 2010; 03: 2.
11. Sultana N, Arayne MS, Siddiqui FA. Determination and quantification of Cetirizine hydrochloride in dosage formulations by RP-HPLC. Pakistan Journal of Pharmaceutical Sciences 2005; 18(3): 7-11.
12. Kücükgüzel I, Karakus S, Küҫükgüzel SG. Development and validation of a rapid RP-HPLC method for the determination of Cetirizine or Fexofenadine with Pseudoephedrine in binary pharmaceutical dosage forms. Journal of Pharmaceutical and Biomedical Analysis 2008; 46: 295–302.
13. Jaber AMY, Al Sherife HA, Al Omari MM, Badwan AA. Determination of Cetirizine dihydrochloride, related impurities and preservatives in oral solution and tablet dosage forms using HPLC. Journal of Pharmaceutical and Biomedical Analysis 2004; 36: 341-350.
14. El Walily AFM, Korany MA, El Gindy A, Bedair MF. Spectrophotometric and high performance liquid chromatographic determination of Cetirizine dihydrochloride in pharmaceutical tablets. Journal of Pharmaceutical and Biomedical Analysis 1998; 17: 435-442.
15. Bajerski L, Sangoi MS, Barth T, Diefenbach IF. Determination of Cetirizine in tablets and compounded capsules: comparative study between CE and HPLC. Quim. Nova. 2010; 33(1): 114-118.
16. Chien D, Schoenwald RD. Fluorometric determination of Phenylephrine hydrochloride by liquid chromatography in human plasma. Journal of Pharmaceutical Sciences 1985; 74(5): 562-564.
17. Devarajan PV, Adani MH, Gandhi AS. Simultaneous determination of Lignocaine hydrochloride and Phenylephrine hydrochloride by HPTLC. Journal of Pharmaceutical and Biomedical Analysis 2000; 22: 685-690.
18. Makhija NS, Vavia RP. Stability indicating HPTLC method for the simultaneous determination of Pseudoephedrine and Cetirizine in pharmaceutical formulations. Journal of Pharmaceutical and Biomedical Analysis 2001; 25: 663–667.
19. Dhongle SP, Sahare JS, Dhongle SS, Mundhey SA, Wate PS. Development and validation of HPTLC method for simultaneous estimation of Cetirizine hydrochloride and Phenylpropanolamine hydrochloride in tablet dosage form. Der Pharmacia Lettre. 2011; 3 (4): 111-119.
20. Patel BA, Patel GS, Patel PD, Patel HB, Patel MM. Stability indicating HPTLC method development and validation for estimation of Ambroxol hydrochloride and Cetirizine dihydrochloride in combine tablet dosage form. International Research Journal of Pharmacy 2011; 2(3): 95-99.
21. Schieffer WG, Hughes ED. Simultaneous stability-indicating determination of Phenylephrine hydrochloride, Phenylpropanolamine hydrochloride, and Guaifenesin in dosage forms by reversed-phase paired-ion high-performance liquid chromatography. Journal of Pharmaceutical Sciences 1983; 72(1): 55-59.
2. Indian Pharmacopoeia, Volume II, Government of India, Ministry of Health and Family Welfare, Published by The Indian Pharmacopoeia Commission, Ghaziabad 2007, pp. 893-894.
3. Beyene NW, Van Staden JF. Sequential injection spectrophotometric determination of Phenylephrine hydrochloride in pharmaceutical preparations. Talanta 2004; 63: 599-604.
4. Drozd J, Hopkala H, Misztal G, Paw B. Applications of derivative UV- spectrophotometry for the determination of Cetirizine dihydrochloride in preparations. Acta Poloniae Pharmaceutica- Drug Research 2002; 59(1): 3-7.
5. El Walily AFM, Korany MA, El Gindy A, Bedair MF. Spectrophotometric and high performance liquid chromatographic determination of Cetirizine dihydrochloride in pharmaceutical tablets. Journal of Pharmaceutical and Biomedical Analysis 1998; 17: 435-442.
6. Maithani M, Raturi R, Gautam V, Kumar D, Chaudhary AK, Gaurav A, Singh R. Development and validation of a RP-HPLC method for the determination of Chlorpheniramine maleate and Phenylephrine in pharmaceutical dosage form. Pharmacie Globale International Journal of Comprehensive Pharmacy 2010; 5: 5.
7. Wagh RS, Hajare RA, Tated AG, Gadbail PA, Khan FA, Kayal SD. Method development and validation for simultaneous determination of Ebastine and Phenylephrine hydrochloride in tablet formulation by RP-HPLC. International Journal of Pharmaceutical Research and Development 2011; 3(7): 214-220.
8. Demiralay E, Mehmet G, Canbay H. Validation of method for simultaneous determination of Paracetamol and Phenylephrine in pharmaceutical formulation by reversed phase liquid chromatography. Pharmacie Globale International Journal of Comprehensive Pharmacy 2011; 09: 6.
9. Pirol O, Sukuroglu M, Ozden T. Simultaneous determination of Paracetamol, Phenylephrine hydrochloride, Oxolamine citrate and Chlorpheniramine maleate by HPLC in pharmaceutical dosage forms. E-Journal of Chemistry 2011; 8(3): 1275-1279.
10. Maithani M, Raturi R, Gautam V, Kumar D, Gaurav A, Singh R. Simultaneous estimation of Ambroxol hydrochloride and Cetirizine hydrochloride in tablet dosage form by RP-HPLC method. Pharmacie Globale International Journal of Comprehensive Pharmacy 2010; 03: 2.
11. Sultana N, Arayne MS, Siddiqui FA. Determination and quantification of Cetirizine hydrochloride in dosage formulations by RP-HPLC. Pakistan Journal of Pharmaceutical Sciences 2005; 18(3): 7-11.
12. Kücükgüzel I, Karakus S, Küҫükgüzel SG. Development and validation of a rapid RP-HPLC method for the determination of Cetirizine or Fexofenadine with Pseudoephedrine in binary pharmaceutical dosage forms. Journal of Pharmaceutical and Biomedical Analysis 2008; 46: 295–302.
13. Jaber AMY, Al Sherife HA, Al Omari MM, Badwan AA. Determination of Cetirizine dihydrochloride, related impurities and preservatives in oral solution and tablet dosage forms using HPLC. Journal of Pharmaceutical and Biomedical Analysis 2004; 36: 341-350.
14. El Walily AFM, Korany MA, El Gindy A, Bedair MF. Spectrophotometric and high performance liquid chromatographic determination of Cetirizine dihydrochloride in pharmaceutical tablets. Journal of Pharmaceutical and Biomedical Analysis 1998; 17: 435-442.
15. Bajerski L, Sangoi MS, Barth T, Diefenbach IF. Determination of Cetirizine in tablets and compounded capsules: comparative study between CE and HPLC. Quim. Nova. 2010; 33(1): 114-118.
16. Chien D, Schoenwald RD. Fluorometric determination of Phenylephrine hydrochloride by liquid chromatography in human plasma. Journal of Pharmaceutical Sciences 1985; 74(5): 562-564.
17. Devarajan PV, Adani MH, Gandhi AS. Simultaneous determination of Lignocaine hydrochloride and Phenylephrine hydrochloride by HPTLC. Journal of Pharmaceutical and Biomedical Analysis 2000; 22: 685-690.
18. Makhija NS, Vavia RP. Stability indicating HPTLC method for the simultaneous determination of Pseudoephedrine and Cetirizine in pharmaceutical formulations. Journal of Pharmaceutical and Biomedical Analysis 2001; 25: 663–667.
19. Dhongle SP, Sahare JS, Dhongle SS, Mundhey SA, Wate PS. Development and validation of HPTLC method for simultaneous estimation of Cetirizine hydrochloride and Phenylpropanolamine hydrochloride in tablet dosage form. Der Pharmacia Lettre. 2011; 3 (4): 111-119.
20. Patel BA, Patel GS, Patel PD, Patel HB, Patel MM. Stability indicating HPTLC method development and validation for estimation of Ambroxol hydrochloride and Cetirizine dihydrochloride in combine tablet dosage form. International Research Journal of Pharmacy 2011; 2(3): 95-99.
21. Schieffer WG, Hughes ED. Simultaneous stability-indicating determination of Phenylephrine hydrochloride, Phenylpropanolamine hydrochloride, and Guaifenesin in dosage forms by reversed-phase paired-ion high-performance liquid chromatography. Journal of Pharmaceutical Sciences 1983; 72(1): 55-59.
Published
01-07-2012
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“DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF CETIRIZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE IN TABLETS”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 4, no. 3, July 2012, pp. 222-6, https://doi.org/10.25004/IJPSDR.2012.040311.
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How to Cite
“DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF CETIRIZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE IN TABLETS”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 4, no. 3, July 2012, pp. 222-6, https://doi.org/10.25004/IJPSDR.2012.040311.
