Development and Validation Method for Simultaneous Investigation of Ambroxol Hydrochloride and N-Acetyl Cysteine In Bulk And Pharmaceutical Formulation By RP-HPLC.
A simple, precise and rapid reverse phase HPLC- SPD 20-Amethod has been developed and validated for the simultaneous investigation of Ambroxol Hydrochloride (AMB) and N-Acetyl Cysteine (NAC) in tablet dosage form. The mixture of (AMB) and (NAC) was separated on C18 5µm.column (4.5 µm × 25 cm). All separation were monitored with a SPD-20A UV-Vis detector on 210 – 400 nm wavelength at ambient temperature and flow rate of 1 ml/min. The mobile phase was phosphate buffer: acetonitrile (75:25) and pH 2.5 adjusted with dilute ortho-phosphoric acid. The retention time of AMB and NAC were found to be 8.4024 and 3.35088 respectivelythe resolution was 9.86346. The method was mean recoveries in the range of 100.4 to 100.15 for all components. The developed method can be use for the routine analysis of AMB and NAC in tablet dosage form.
2. Bernhard H. Lauterburg C GB. 6. Bernhard H. Lauterburg C, George B. Corcoran M. Mechanism of Action of N-Acetylcysteine in the protection against the hepatotoxicity of Acetaminophen in rats In vivo. Journal of Clinical Investigation, (1983); 71(4): 980–991.
3. Skoog DA, Holler FJ, Crouch SR. 2009. Instrumental Analysis. New Delhi, India: Cengage Learning India Private Limited.
4. Kasture AV, Wadodkar SG, Mahadik KR, More HM. 2006. A textbook of Pharmaceutical Analysis.14th ed, Vol II. 1-2.
5. Beckett AH, Stenlake JB. 2002. Practical Pharmaceutical Chemistry. New Delhi India: CBS Publishers and Distributors. 4th ed, Vol II. 278-281.
6. Katsuyuki T, Nobuaki M SM. 5. Katsuyuki T, Nobuaki M, Shigeki M. Immunomodulatory effects of Ambroxol on airway hyper responsiveness and inflammation. Journal of Immune Network, 2016: 16 (3): 165 -175.
7. Alison L. 7. Alison L. Mechanism of action and value of N-Acetylcysteine in the treatment of early and late acetaminophen poisoning: A Critical Review. Journal of Toxicology. 1998; 36 (4): 277-285.
8. Mankaran S, Dinesh K, Gurmeet S. Simultaneous Estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride in Pharmaceutical Tablet Dosage Form by Simultaneous Equation Spectrophotometric Method: A Quality Control Tool for Dissolution Studies. International Scholarly Research Notices. 2014:6.
9. Selvadurai M, Jaya K, Sokkalingam A. Development and validation of an high-performance liquid chromatographic, and a ultraviolet spectrophotometric method for determination of Ambroxol hydrochloride in pharmaceutical preparations. Journal of Pharmaceutical Technology and Research. 2013; 4(1): 65 -68.
10. Elkady Y, El-Adl SM, Baraka M, Sebaiy M. HPLC Method for Simultaneous Determination of Ambroxol, Salbutamol and Fexofenadine in Their Bulk and Dosage Forms. Journal of Pharmaceutical Sciences and Biomedical Analysis. 2020; 3 (1): 121.
11. Sreenivasa C, Sridhar C, Chandrasekhar K. Quantitative determination of N-Acetyl cysteine by RP-HPLC method in bulk and parenteral injection. Asian Journal of Pharmacy and Pharmacology. 2018; 4(5): 702-705.
12. Lea K, Njegomir R. Spectrophotometric Determination of N-Acetyl-L-Cysteine and N-(2-Mercaptopropionyl)-Glycine in Pharmaceutical Preparations. International Journal of Analytical Chemistry. 2011: 140 -146.
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