Stability Indicating Method Development and Validation for the Simultaneous Estimation of N-Acetylcysteine and Acebrophylline in Tablet Dosage form by RP-HPLC

Shriya.N; Dr. S. Shobha Rani; Dr. M. Ajitha; Dr. Y. Sridhar Reddy; Sumit Agarwal; Karthik.M; Narendhar.D1

1

Publication Date: 2024/08/28

Abstract: A quick, accurate, precise Stability indicating method for Simultaneous estimation of N-Acetylcysteine and Acebrophylline in Tablet dosage form was developed and validated. Chromatogram was run on Waters C18 (150 x 4.6 mm, 2 μm) Column. Mobile phase containing OPA Buffer and Methanol taken in a ratio of 10:90 % v/v was pumped at a flow rate of 1.5 mL/min through column. Cushion utilized in this strategy was OPA. Column temperature was kept at 35°C. Injection volume was 5 μL and Run time was 5 minutes. Sample was scanned at 285 nm. RT’s of N-Acetylcysteine and Acebrophylline were found to be 2.646 min and 2.117 min respectively. The developed method was validated and was found to be Accurate, Precise and Linear over the Concentration Range of 25 % to 175 % of Test concentration. Retention time and Runtime are less and the method was properly validated so this method can be utilized for routine analysis and stability studies of Assay of N-Acetylcysteine and Acebrophylline in Tablet dosage form in industries.

Keywords: N-Acetylcysteine, Acebrophylline, Stability Indicating, Simultaneous Estimation, Tablet Dosage form, RP-HPLC.

DOI: https://doi.org/10.38124/ijisrt/IJISRT24AUG1164

PDF: https://ijirst.demo4.arinfotech.co/assets/upload/files/IJISRT24AUG1164.pdf

REFERENCES

  1. Kathirvel S*, Indukala P.C1, Sruthi Mohan1, Gayathri Ramya, Rajesh A. A New Stability Indicating RP-HPLC Method for Simultaneous Estimation of Acebrophylline and N-Acetylcysteine in Tablet Dosage Form and Its Validation as Per ICH Guidelines. International Journal of Pharmacy and Pharmaceutical Research. 2019, 16(2), 422-435.
  2. Sravani Takkarusu, Sridhar Thota, Venisetty Raj Kumar, Venumadhav Neerati. RP-HPLC Analysis of Acebrophylline in API and Capsule Dosage Form. Research Journal of Pharmaceutical, Biological and Chemical Sciences. 2014 5(1), 480-6.
  3. Nitin S, Jadhav and Lalitha KG. Development and validation of spectroscopic method for simultaneous estimation of Acebrophylline and Acetylcysteine in capsule dosage form. Int. J. Pharm and Phytopharmacological Research. 2014 4(2), 113-115.
  4. ICH Validation of Analytical Procedures: Text and Methodology Q2 (R1). International Conference on Harmonisation.
  5. ICH Stability Testing of New Drug Substances and Products Q1A (R2). International Conference on Harmonisation.
  6. Sharma Bhavik,   Agarwal Sushil Kumar. RP-HPLC Method Development and Validation for Estimation of Acebrophylline. Asian Journal of Pharmaceutical   Research and Development. 2018 6 (6), 56-59.
  7. Tripathi  KD. Essentials of Medical Pharmacology.  6th edition. New Delhi: Jaypee Brothers Medica Publishers Ltd, 2010.
  8. Nalluri Naga Jyothi*, Syed Imam Pasha. Development and Validation of a New Rp-Hplc Method For Simultaneous Estimation of N-Acetylcysteine and L – Arginine in Combined Dosage form. Orient J Chem. 2014, 30(3), 1371-1378.
  9. Dhaneshwar SR and Jagtap VN. Development and validation of stability indicating RP-HPLC-PDA method for determination of acebrophylline and its application for formulation analysis and dissolution study. Journal of Basic and Applied Scientific Research, 2011, 1(11), 1884-90.
  10. Tvinkal P. Patel, Laxman M. Prajapati, Amit K. Joshi, Mohammadali L. Kharodiya.Q-Absorbance Ratio Method for Simultaneous Estimation of Acetylcysteine and Acebrophylline. World Journal of Pharmaceutical Research. .2015,4(5), 1808-1816.