SIMULTANEOUS ESTIMATION OF LORATADINE AND AMBROXOL HYDROCHLORIDE IN BULK AND PHARMACEUTICAL FORMULATIONS BY SIMPLE UV SPECTROPHOTOMETRY

Authors

  • ABHISHEK KAMBLE Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola, Maharashtra, India
  • ASHPAK TAMBOLI Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola, Maharashtra, India
  • AJINKYA ZADE Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola, Maharashtra, India
  • KIRAN PATIL Department of Pharmaceutical Chemistry, Sahyadri College of Pharmacy, Methwade, Sangola, Maharashtra, India

DOI:

https://doi.org/10.22159/ijcpr.2024v16i5.5057

Keywords:

Loratadine, Ambroxol hydrochloride, Simultaneous estimation, ICH guidelines

Abstract

Objective: The simple, rapid, accurate, precise and cost-effective UV spectrophotometric methods have been developed and validated for simultaneous estimation of Loratadine and Ambroxol Hydrochloride in tablet dosage form.

Methods: The UV methods have been developed utilizing concept of standard addition utilizing Methanol: Water (50:50%, v/v) as a solvent. Method is estimation using simultaneous equation method at 305 nm (λmax of Loratadine) and 242 nm (λmax of Ambroxol Hydrochloride).

Results: Linearity was observed in range of 5-25 μg/ml each for Loratadine and Ambroxol Hydrochloride, respectively for methods. The correlation coefficient (r2) value was found to be values in the range of 0.9941-0.9961. The assay result of marketed formulation was found to be 99.98 % and 100.07 % of Loratadine and Ambroxol Hydrochloride.

Conclusion: The present result shows that the proposed method can be successfully implemented for estimation of Loratadine and Ambroxol Hydrochloride in bulk and its marketed formulations. Methods were statistically validated as per ICH guidelines and can be successively applied for analysis for tablets formulation.

Downloads

Download data is not yet available.

References

Gandhimathi R, Vijayaraj S, Jyothirmaie MP. Analytical process of drugs by ultraviolet (UV) spectroscopy a review. Int J Pharm Res Anal. 2012;2(2):72-8.

Gandhi LR. Stress degradation studies and development of stability indicating assay method for simultaneous estimation of ambroxol hydrochloride and salbutamol sulphate in bulk and its formulation. Asian J Pharm Res Dev. 2018;6(6):44-9. doi: 10.22270/ajprd.v6i6.453.

Ramulu G. A new validated liquid chromatographic method for the determination of loratadine and its impurities. Sci Pharm. 2011;79(2):277-91. doi: 10.3797/scipharm.1012-13.

Rele RV, Gurav PJ. A simple extractive spectrophotometric determination of loratadine desloratadine and rupatadine from pharmaceutical formulations. Int J Pharm Biol Sci. 2012;3(2):89-95.

Indian Pharmacopoeia. Vol III. Ministry of health and family welfare. J Published by Indian Pharmacopoeia Commission; 2007. p. 83.

British Pharmacopeia. Vol. I, II. Published by British Pharmacopoeia Commission; 2009. p. 265-8.

Tripathi KD. Essential of Medical Pharmacology. 6th ed. Jaypee Brothers Medical Publisher (P) LTD; 2008. p. 214.

Sreenivasulu Reddy T, Nagabhushana Reddy K, Giri A. Estimation of ambroxol hydrochloride in bulk and pharmaceutical formulations by simple visible spectrophotometry. Int J Pharm Sci Rev Res. 2014 May-Jun;26(1):32-6.

ICH, Topic Q2(R1) Validation of analytical procedures text and methodology; 1995.

ICH Tripartite Guidelines, Q2R1 validation of analytical procedures. Geneva, Switzerland: Text and Methodology, ICH; 2005.

ICH Tripartite Guidelines, Q2B validation of analytical procedures: text and methodology. Geneva, Switzerland: ICH; 1996.

Published

15-09-2024

How to Cite

KAMBLE, A., A. TAMBOLI, A. ZADE, and K. PATIL. “SIMULTANEOUS ESTIMATION OF LORATADINE AND AMBROXOL HYDROCHLORIDE IN BULK AND PHARMACEUTICAL FORMULATIONS BY SIMPLE UV SPECTROPHOTOMETRY”. International Journal of Current Pharmaceutical Research, vol. 16, no. 5, Sept. 2024, pp. 45-49, doi:10.22159/ijcpr.2024v16i5.5057.

Issue

Section

Original Article(s)