Author(s): Sridevi. S, Vijayakumar. R, C. N. Nalini

Email(s): ssreedevi2501@gmail.com

DOI: 10.5958/0974-360X.2020.00344.3   

Address: Sridevi. S*, Vijayakumar. R, C. N. Nalini
Department of Pharmaceutical Analysis, C. L. Baid Metha College of Pharmacy, Chennai-97, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 4,     Year - 2020


ABSTRACT:
An accurate, precise RP-HPLC method was developed for the simultaneous estimation of Ascorbic acid (ASC), Phenylephrine HCl (PHE), Paracetamol (PAR), Levocetirizine HCl (LEV) in tablet dosage form and has been validated as per ICH guidelines. A gradient method was developed using column Aegispak C18 (25cm x 4.6mm, 5µm) and phosphate buffer pH 4.0±0.05, Acetonitrile. The detection was done using wavelength of 220nm. The flow rate was 1.5mL/minute and load volume was 50µL. The retention time of ascorbic acid, phenylephrine HCl, paracetamol, levocetirizine HCl was found to be 2.4±0.1, 5.4±0.1, 10.0±0.1, and 22.7±0.1 respectively. The method was linear in concentration ranges of 50 to 150 % and R2 was found to be with in the limit. The result of accuracy was found to be between 98 to 102%. The method was precise as the % RSD was found that NMT 2.0%. Specificity studies reveals no interference in the standard peaks due to placebo and diluent effect. The developed precise method was validated in respect to linearity, range, precision, accuracy, robustness.


Cite this article:
Sridevi. S, Vijayakumar. R, C. N. Nalini. Method Development and Validation for the Simultaneous Estimation of Ascorbic acid, Phenylephrine HCl, Paracetamol and Levocetirizine HCl using RP-HPLC. Research J. Pharm. and Tech. 2020; 13(4):1911-1916. doi: 10.5958/0974-360X.2020.00344.3


REFERENCES:
1.    "Ascorbic Acid". The American Society of Health-System Pharmacists. Archived from the original on December 30, 2016. Retrieved December 8, 2016.
2.    Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids. Washington, DC: The National Academies Press. 2000. pp. 95–185. ISBN 978-0-309-06935-9. Archived from the original on September 2, 2017. Retrieved September 1, 2017.
3.    "Phenylephrine Hydrochloride Monograph for Professionals". Drugs.com. AHFS. Retrieved 10 January 2019.
4.    British national formulary: BNF 76 (76, 1140 ed.). Pharmaceutical Press. 2018. pp. 188–189. ISBN 9780857113382.
5.    "Acetaminophen". The American Society of Health-System Pharmacists. Archived from the original on 5 June 2016. Retrieved 16 September 2016.
6.    "Acetaminophen". The American Society of Health-System Pharmacists. Archived from the original on 3 March 2011. Retrieved 3 April 2011.
7.    Sin, B; Wai, M Tatunchak, T Motov, SM (29 January 2016). "The use of intravenous acetaminophen for acute pain in the emergency department". Academic Emergency Medicine. 23 (5): 543–53. doi:10.1111/acem.12921. PMID 26824905.
8.    "Levocetirizine Dihydrochloride Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Retrieved 22 March 2019.
9.    Anandakumar K, Veerasundari P. Simultaneous estimation of paracetamol, ambroxol hydrochloride, levocetirizine dihydrochloride, and phenylephrine hydrochloride in combined tablet formulation by first-order derivative spectrophotometry. ISRN Spectroscopy. 2014 Mar 30;2014.
10.    Gharge D, Raut C, Dhabale P. Simultaneous Estimation of Aceclofenac and Paracetamol in Solid Dosage Form by UV Spectrophotometry. Research Journal of Pharmacy and Technology. 2010;3(1):247-50.
11.    Ostwal PP, Jadhav YL, Jain MS, Jain SP. Dissolution Profiling of Bilayered Conventional Release Paracetamol and Sustained Release Ibuprofen (By Simultaneous Estimation Method UV). Research Journal of Pharmacy and Technology. 2012 Apr 1;5(4):490.
12.    Ahmed R, Supriya RS, Sheetal DR. Spectrophotometric Method for Simultaneous Estimation of Paracetamol and Cinnarizine in Tablet Dosage Forms. Research Journal of Pharmacy and Technology. 2012 May 1;5(5):667.
13.    Lokhande SR, Pekamwar SS, Kalyankar TM. Development and Validation of Spectrophotometric Method for Estimation of Mefenamic Acid and Paracetamol in Bulk and in Pharmaceutical Formulation by Simultaneous Equation Method. Research Journal of Pharmacy and Technology. 2012 Sep 1;5(9):1201.
14.    Oza. C.K, Nijhawan. R, Pandya. M.K, Vyas. A.J, A.I. Patel. Dual Wavelength Spectrophotometric method for the simultaneous determination of Paracetamol and Nabumetone in API and in tablet dosage form. Asian J. Pharm. Ana. 2(4): Oct. - Dec. 2012; Page 122-127.
15.    Dyade. G.K. Validated Derivative Spectrophotometric method for simultaneous estimation of Levocetirizine Dihydrochloride and Phenylephrine Hydrochloride from tablet formulations. Asian J. Pharm. Ana. 2019; 9(1):01-04.
16.    Kumudhavalli. M.V, Saravanan. C, Kumar. M, Jayakar. B.  Determination of Psuedoephedrine Hydrochloride, Cetirizine Dihydrochloride and Paracetamol in Uncoated Tablet by RP-HPLC. Journal of Global Pharma Technology. 2010; 2(4):97-101
17.    Palabıyık IM, Onur F. The simultaneous determination of phenylephrine hydrochloride, paracetamol, chlorpheniramine maleate and dextromethorphan hydrobromide in pharmaceutical preparations. Chromatographia. 2007 Sep 1;66(1):93-6.
18.    Marin. A, Garcia. A. Simultaneous Determination of Paracetamol, Phenylephrine and Chlorpheniramine by RP-HPLC.J Pharm Biomed Ana. 2004, 10(9), 769-777.
19.    Lohar V.R, Mane Aruna, Chavanjaykar, Palled M.S. Bhat A.R. Simultaneous Estimation of Paracetamol, Caffeine, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Loratadine in Tablet Dosage form by RP-HPLC. Asian J. Research Chem. 4(7): July, 2011; Page 1141-1147.
20.    Sekar V, Bajivali SK, Vanitha C, Jayaseelan S, Perumal P. RP-HPLC Method Development and Validation for Simultaneous Estimation of Ambroxol and Levocetirizine in Solid Dosage Form. Asian Journal of Research in Chemistry. 2011;4(7):1097-9.
21.    Abhishek K Jain, Jain. C.P, Anshu Sharma. Reverse Phase - High Performance Liquid Chromatography Method for the Analysis of Paracetamol. Research J. Pharm. and Tech.2 (4): Oct.-Dec. 2009; Page701-704.
22.    Kothapalli LP, Yadav AH, Pawar HI, Dewoolkar VC, Banerjee AG, Thomas AB, Deshpande AD. RP-HPLC Method for Determination of Aceclofenac, Chlorzoxazone and Paracetamol in Bulk and Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 2009;2(1):161-3.
23.    Suganthi. A, Ravi. T.K. Development and Validation of a Novel Stability Indicating High – Performance Liquid Chromatography Method for Simultaneous Determination of Paracetamol and Lornoxicam. Research J. Pharm. and Tech. 4(7): July 2011; Page 1046-1051.
24.    Nehal Fayek Farid, Eglal. A, Abdelaleem. HPTLC Method for the Determination of Paracetamol, Pseudoephedrine and Loratidine in Tablets and Human Plasma J Chromatogr Sci. 2016 Apr; 54(4): 647–652.
25.    Sagar. S, Vidhate, Sachin. E et al. Development and validation of HPTLC method for simultaneous quantification of Paracetamol, Phenylephrine hydrochloride, Nimesulide, Cetrizine and Caffeine in bulk and pharmaceutical dosage form. Der Pharmacia Sinica, 2015, 6(7):1-8
26.    Chaube PH, Gandhi SV, Deshpande PB, Kulkarni VG. High Performance Thin Layer Chromatographic Analysis of Paracetamol and Etoricoxib in Spiked Human Plasma. Research Journal of Pharmacy and Technology. 2011;4(8):1303-6.
27.    Anuruddha R. Chabukswar, Vishakha G. Thakur et al. Development and Validation of HPTLC Method for Simultaneous Estimation of Paracetamol, Ibuprofen and Caffeine in Bulk and Pharmaceutical Dosage Form. Research J. Pharm. and Tech. 5(9): September 2012; Page 1218-1222.
28.    Hamid Khan, Mushir Ali, Alka Ahuja, Javed Ali. Validated UPLC/Q-TOF-MS Method for Simultaneous Determination of Aceclofenac, Paracetamol and Chlorzoxazone in Human Plasma and its Application to Pharmacokinetic Study. Asian J. Pharm. Ana. 2017; 7(2): 93-99.
29.    Anil P. Dewani, Srdhanjalipatra. A single HPLC-DAD method for simultaneous estimation analysis of paracetamol, phenylephrine, caffeine and levocetirizine in bulk powder and tablet formulation: Application to in-vitro dissolution studies. J. Chil. Chem. Soc., 60, N° 4 (2015)
30.    Koblova P, Sklenarova H, Brabcova I, Solich P. Development and validation of a rapid HPLC method for the determination of ascorbic acid, phenylephrine, paracetamol and caffeine using a monolithic column. Analytical Methods. 2012;4(6):1588-91.
31.    Padmakana Malakar, Arup Ratan Deb, Soumitra Adhikary, Siraj Ahmed, Ravi Maloth. Simultaneous estimation of phenylephrine hydrochloride, paracetamol, caffeine and cetirizine dihydrochloride from tablet dosage form using RP-HPLC. International Journal of Biological & Pharmaceutical Research. 2013; 4(5): 368-376.
32.     Anna Pratima G. Nikalje, Ramesh Gadikar and Shankar Turwale.  A simple stability indicating HPLC method for simultaneous determination of levocetirizine dihydrochloride, phenylephrine hydrochloride and paracetamol in pharmaceuticals. IJPSR, 2019; Vol. 10(5): 2497-2503.
33.    Validation of Analytical Procedures: Text and Methodology Q2 (R1), ICH Harmonized Tripartite Guideline 2005: 113.

Recomonded Articles:

Author(s): Nimbalkar V.V., Pansare P.M., Nishane B.B.

DOI: 10.5958/0974-360X.2015.00310.8         Access: Open Access Read More

Author(s): Mukta D. Naykode, Durgacharan A. Bhagwat, Swapnil D. Jadhav, Harinath N. More

DOI: 10.5958/0974-360X.2017.00133.0         Access: Open Access Read More

Author(s): Mayanka Singh, Manoj Charde, Rajesh Shukla, Rita M. Charde

DOI: Not Available         Access: Open Access Read More

Author(s): Rekha Rajendran, R Hemachander, T Ezhilarasan, C Keerthana, DL Saroja, KV Saichand, Mohamed Gasim Abdullah

DOI: Not Available         Access: Open Access Read More

Author(s): Krishnendu Acharya*, Somanjana Khatua, Salman Sahid

DOI: Not Available         Access: Open Access Read More

Author(s): Oruganti Sai Koushik, V. Himaja, P. Srinivasa Babu, Ramadoss Karthikeyan

DOI: 10.5958/0974-360X.2015.00298.X         Access: Open Access Read More

Author(s): Subin Mary Zachariah, N. Aleykutty, Vidya Viswanad, Halima O.A.

DOI: Not Available         Access: Open Access Read More

Author(s): U.S MahadevaRao, Khamsah Suryati Mohd, Siti Zulaikha Bt Abd Halim, Masitah Bt Khamis

DOI: Not Available         Access: Open Access Read More

Author(s): J.S. Vaghela, S.S. Sisodia

DOI: Not Available         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 


Recent Articles




Tags