SIMULTANEOUS QUANTITATION AND VALIDATION OF PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE AND CETIRIZINE HYDROCHLORIDE BY RP-HPLC IN BULK DRUG AND FORMULATION
Abstract
A HPLC method has been described for simultaneous determination of Paracetamol, Phenylpropanolamine hydrochloride and Cetirizine hydrochloride in formulation. This method is based on HPLC separation of the three drugs on the Thermo Hypersil Gold C18 column (250 mm × 4.6 mm, 5.0µ), with isocratic conditions and mobile phase containing methanol: 0.01M disodium hydrogen phosphate dihydrate buffer [pH 7, adjusted with Ortho Phosphoric Acid (OPA)] (60: 40) at a flow rate of 1 ml/min, using UV detection at 217 nm. This method has been applied to formulation without any interference of excipients of formulation. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 0.4-1.4µg/ml for Paracetamol, 7-12µg/ml for Phenylpropanolamine hydrochloride and 5-10µg/ml for Cetirizine hydrochloride respectively. The mean values of the correlation coefficient, slope and intercept were 0.9993, 51489 and 5844.4 for Paracetamol, 0.9991, 23235 and 70540 for Phenylpropanolamine hydrochloride and 0.9990, 40416 and 93404 for Cetirizine hydrochloride respectively. The method was validated as per the ICH guidelines. The limit of detection (LOD) and limit of quantitation (LOQ) was 0.2μg/ml and 0.4μg/ml for Paracetamol, 5μg/ml and 7μg/ml for Phenylpropanolamine hydrochloride and 4µg/ml and 5µg/ml for Cetirizine hydrochloride, respectively. Statistical analysis showed that the method is repeatable and selective for the estimation of Paracetamol, Phenylpropanolamine hydrochloride and Cetirizine hydrochloride.
Keywords:
Paracetamol, Phenylpropanolamine hydrochloride, Cetirizine hydrochloride, HPLC, Validation.DOI
https://doi.org/10.25004/IJPSDR.2011.030406References
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26. Azhagvuel S, Sekar R. Method development and validation for the simultaneous determination of Cetirizine dihydrochloride, Paracetamol and Phenylpropanolamine hydrochloride in tablets by capillary zone electrophoresis. Journal of Pharmaceutical and Biomedical Analysis 2007; 43: 873–878.
27. ICH Q2 (R1), Validation of analytical procedures: text and methodology, International conference on harmonization, Geneva 2005.
2. Lemke TL, Williams DA. Foye’s Principles of Medicinal Chemistry. Edn 6, Wolters Kluwer (India) Pvt. Ltd. New Delhi, pp. 407.
3. Gopinath R, Rajan S, Meyyanathan SN, Krishnaveni N, Suresh B. A RP-HPLC method for simultaneous estimation of paracetamol and aceclofenac in tablets. Indian Journal of Pharmaceutical sciences 2007; 69(1): 137-140.
4. Karthikeyan V, Vaidhyalingam, Yuvaraj G, Nema RK. Simultaneous Estimation of Paracetamol, Chlorzoxazone and Aceclofenac in Pharmaceutical Formulation by HPLC Method. International Journal of ChemTech Research 2009; 3: 457-460.
5. Karthik A, Subramanian G, Ranjith Kumar A, Udupa N. Simultaneous estimation of paracetamol and domperidone in tablets by reverse phase HPLC method. Indian Journal of Pharmaceutical Sciences 2007; 69(1): 142-144.
6. Pattan SR, Jamdar SG, Godge RK, Dighe NS, Daithankar AV, Nirmal SA, Pai MG. RP- HPLC Method for Simultaneous Estimation of Paracetamol and Etoricoxib from Bulk and Tablets. Journal of Chemical and Pharmaceutical Research 2009; 1(1): 329-335.
7. Battu PR, Reddy MS. RP-HPLC Method for Simultaneous Estimation of Paracetamol and Ibuprofen in Tablets. Asian Journal of Research Chem 2009; 2(1): 70-72.
8. Battu PR. Simultaneous RP-HPLC Determination of Nimesulide and Paracetamol in Tablets. International Journal of PharmTech Research 2009; 1(3): 514-516.
9. Subramanian G, Shetty A, Agarwal S, Pandey S, Udupa N. Simultaneous reverse phase HPLC estimation of paracetamol and rofecoxib in tablets. Indian Journal of Pharmaceutical Sciences 2005; 67(2): 247-249.
10. Hadada GM, Emarab S, Waleed MMM. Development and validation of a stability-indicating RP-HPLC method for the determination of paracetamol with dantrolene or/and cetirizine and pseudoephedrine in two pharmaceutical dosage forms. Talanta 2009; 79: 1360-1367.
11. Hewala II. Stability - Indicating HPLC Assay for Paracetamol, Guaiphenesin, Sodium Benzoate and Oxomemazine in Cough Syrup. Analytical Letters 1994; 27(1): 71 – 93.
12. Indrayanto G, Sunarto A, Adriani Y. Simultaneous assay of Phenylpropanolamine hydrochloride, Caffeine, Paracetamol, Glycerylguaiacolate and Chlorpheniramine maleate in Silabat TM tablet using HPLC with diode array detection. Journal of Pharmaceutical and Biomedical Analysis 1995; 13: 1555-1559.
13. Akhtar MJ, Khan S, Hafiz M. High-performance liquid chromatographic assay for the determination of Paracetamol, Pseudoephedrine hydrochloride and Triprolidine. Journal of Pharmaceutical and Biomedical Analysis 1994; 12(3): 379-382.
14. Heitmeier S, Blaschke G. Direct determination of Paracetamol and its metabolites in urine and serum by capillary electrophoresis with ultraviolet and mass spectrometric detection. Journal of Chromatography B 1999; 721: 93–108.
15. Basavaraj S, Nagaralli, Seetharamappa J, Gowda BG, Melwanki MB. Liquid chromatographic determination of Ceterizine hydrochloride and Paracetamol in human plasma and pharmaceutical formulations. Journal of Chromatography B 2003; 798: 49–54.
16. Bhatia NM, Ganbavale SK, More HN. Spectrophotometric estimation of Ambroxol hydrochloride and Cetirizine hydrochloride in tablets. Asian Journal of Pharmaceutics 2008; 2(3): 159-162.
17. 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. International Journal of Comprehensive Pharmacy 2010; 1(2), 1-3.
18. Khan MI, Murtaza G, Awan S, Iqbal M, Waqas MK, Rasool A, Fatima U, Hassan Bin Asad MH, Kahlid A, Usman F, Najam-us-Saqib Q, Khan SA, Farzana K, Mahmood S, Hussain I. Development and validation of stability indicating assay method of Cetirizine hydrochloride by HPLC. African Journal of Pharmacy and Pharmacology 2011; 5(2): 143-149.
19. Schieffer GW, Hughes DE. 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.
20. Savić I, Nikolić G, Banković V. Development and Validation of Spectrophotometric Method for Phenylephrine hydrochloride Estimation in Nasal Drops Formulations. Macedonian Journal of Chemistry and Chemical Engineering 2008; 27(2): 149–156.
21. Rind FMA, Khuhawar MY, Rajper AD. HPLC determination of Phenylpropanolamine in pharmaceutical preparations using 4-dimethylaminobenzaldehyde as a derivatizing reagent. Journal of Pharmaceutical and Biomedical Analysis 2001; 26: 331–336.
22. Vasudevan M, Ravisankar S, Sathiyanarayanan A, Chandan RS. Simultaneous estimation of Phenylpropanolamine hydrochloride, Guaiphenesin and Diphenylpyraline hydrochloride in syrups by LC. Journal of Pharmaceutical and Biomedical Analysis 2000; 24: 25–31.
23. Gupta A, Nema RK, Sahu A. Simultaneous Estimation of Phenylpropanolamine hydrochloride and Triprolidine hydrochloride in Pharmaceutical Preperations by RP- HPLC Method. The Pharma Research 2009; 01: 67-71.
24. Ferreyra C, Ortiz C. Analysis of multicomponent formulations containing Phenylpropanolamine hydrochloride, Caffeine and Diazepam by using LC. Journal of Pharmaceutical and Biomedical Analysis 2001; 25: 493–499.
25. Nakashima, K, Kanehara, S and Kaddoumi A. HPLC determination of Phenylpropanolamine in pharmaceutical OTC preparations. Biomedical Chromatography 2002; 16: 463–469.
26. Azhagvuel S, Sekar R. Method development and validation for the simultaneous determination of Cetirizine dihydrochloride, Paracetamol and Phenylpropanolamine hydrochloride in tablets by capillary zone electrophoresis. Journal of Pharmaceutical and Biomedical Analysis 2007; 43: 873–878.
27. ICH Q2 (R1), Validation of analytical procedures: text and methodology, International conference on harmonization, Geneva 2005.
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“SIMULTANEOUS QUANTITATION AND VALIDATION OF PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE AND CETIRIZINE HYDROCHLORIDE BY RP-HPLC IN BULK DRUG AND FORMULATION”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 3, no. 4, Oct. 2018, pp. 303-8, https://doi.org/10.25004/IJPSDR.2011.030406.
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Copyright (c) 2011 A. L. Suryan, V. K. Bhusari, K. S. Rasal, S. R. Dhaneshwar
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How to Cite
“SIMULTANEOUS QUANTITATION AND VALIDATION OF PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE AND CETIRIZINE HYDROCHLORIDE BY RP-HPLC IN BULK DRUG AND FORMULATION”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 3, no. 4, Oct. 2018, pp. 303-8, https://doi.org/10.25004/IJPSDR.2011.030406.
