Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Salbutamol Sulphate and Ambroxol Hydrochloride in Oral Liquid Dosage Form
Pharmaceutical analysis is imported branch of science deals with to check the identity, strength, quality and purity of chemical and herbal compounds. Qualitative analysis of drugs and pharmaceutical compounds. Quantitative analysis is of much importance and done by various methods. One of the most accurate and precise methods is spectrophotometry which comprises the measurement of intensity of electromagnetic radiation emitted or absorbed by the compound. Another most popular method of for quantitative analysis is high performance liquid chromatography (HPLC). In the present article a RP-HPLC method was developed for the simultaneous determination of salbutamol sulphate and ambroxol hydrochloride in oral liquid doses form and validation of the developed method. Developed methods include selection of mobile phase, chromatographic method, and wavelength whereas validation involves the system suitability, accuracy, precision, linearity, reproducibility, robustness, specificity and solution stability of the developed method. The result showed that the developed method is the best suited to the simultaneous determination of salbutamol sulphate and ambroxol hydrochloride and validated as per the standards.
2. Sharma BK. 2002. Instrumental Methods of Chemical Analysis. 22nd edn., Krishna prakshan Media Pvt. Ltd: Meerut; C-9, C-292, C-295. Beckett AH, Stenlake JB. 2007. Practical Pharmaceutical Chemistry. Part-II. 4th edn., CBS Publishers and Distributors: New Delhi; 2007;85:86, 92.
3. Douglas A Skoog, Donald M West, James F Holler, Stanley R Crouch. 2007. Fundamentals of Analytical Chemistry. 8th edn., Thomson Asia Pvt. Ltd: Singapore; 4, 921, 975.
4. Sharma BK. 2002. Instrumental Methods of Chemical Analysis. 22nd edn., Krishna prakshan Media Pvt. Ltd: Meerut; C-9, C-292, C-295. Beckett AH, Stenlake JB. 2007. Practical Pharmaceutical Chemistry. Part-II. 4th edn., CBS Publishers and Distributors: New Delhi; 85, 86, 92.
5. Jeffery GH, Bassett J, Mondham J, Denney RC. 1989, Singapore; 5, 216-217., Hobart H
6. Willard, Lynne L Merritt, Jr., John A Dean, Frank A Settle, Jr. 1986. Instrumental Methods of Analysis. 7th edn., CBS Publishers and Distributors: New Delhi; 1, 592, 622-628., Mendham J, Denney RC, Barnes JD, Thomas MJK. 2008, New Delhi; 29, 36,289-295.
7. International Conference on Harmonization, "Q2A: Text on Validation of Analytical Procedures," Federal Register 60(40), 11260–11262 (1995).
8. Lloyd R Slyder, Joseph J Kirkland, Joseph L Glajch. 1997. Practical HPLC Method Development. 2nd edn. John Wiley and Sons, Inc., USA; 22-24, 42, 235-24.
9. Anonymous. 1994. ICH Harmonized Tripartite Guidelines, Text on Validation of Analytical Procedures: Text and Methodology. Q2A. Geneva; 1-8.
10. The United States of Pharmacopeia. 1995. 23/NF, 18, United States of Pharmacopeial Convention, inc., Rock Ville, MD., 1063,1961, 1988, 1990.
11. Gupta SC, Kapoor VK. 1996. Fundamentals of Mathematical Statistics. 9th edn. Sultan Chand and Sons: New Delhi; 2.6, 3.2-3.28.
12. FDA Guidance for industry, Analytical procedures and method validation (draft guidance), August 2000.
13. Szepesi G, 1989 Selection of High performance chromatographic methods in pharmaceutical analysis. J. Chromatograph. 464:265-278. Carr GP, Vahlich JC. 1990 A practical approach to method validation in pharmaceutical analysis, J. Pharmaceutical Biomedical Analysis, 86, 613-618.
14. Indian pharmacopoeia, The Indian pharmacopoeia Commission, Ghaziabad, 2007, Volume-1&2; 143,151, 159, 250, 315, 390, 504, 701, 1176, 1687.
15. Prayas Acharya, Prasanth Kumar, Immanuel Agasteen, Sreerama Rajasekhar, G.Neelima, A Review on Analytical Methods for Determination of Guaifenesin Aloneand In Combination with Other Drugs in Pharmaceutical Formulations,. Saudi Journal of Medical and Pharmaceutical Sciences, 2017, 148-159.
16. Konagala Sravanthi, Bhauvaneswara R. C., Priyanka M.V., Anusha M., Kalyani T, Simultaneous Estimation of Guaifenesin, Levocetirizine Hydrochloride and Ambroxol Hydrochloride in Syrup Dosage form by RP- HPLC, International Journal for Pharmaceutical Research Scholars, 5(1), 2016, 231-258.
17. Ankit B. Chaudhary, Shweta M. Bhadani, Chintal M.Shah ,Development and validation of RP- HPLC, method for Simultaneous Estimation of Bromhexine Hydrochloride, Guaiphenesin and Chlorpheniramine Maleate in Tablet., World Journal of Pharmacy and Pharmaceutical Science2015; 4(5); 1679-1694.
18. Krunal Sagathiya, Hina Bagada , Development and validation of RP-HPLC and HPTLC Method of Analysis for Simultaneous Estimation of Ambroxol Hcl, Dextromethorphan HBR and Guaifenesin in pharmaceutical cough cold preparation and statistical comparison of developed methods., International Journal of Pharmacy and Pharmaceutical Sciences, 6(2), 2014.
19. Manjula T., Nagasowjanya G., Ajitha V., Uma Maheshawara Rao V., Analytical Method Development and Validation for Simultaneous Estimation of Levofloxacin Hemihydrate And Ambroxol HCL in a combined dosage form by RP-HPLC, International Journal of Innovative Pharmaceutical sciences and Research, 2014; 2(9):2179-2188 .
20. Porel A., Sanjuktahaty and Kundu A.,Stability-indicating HPLC Method for Simultaneous determination of Terbutaline Sulphate, Bromhexine Hydrochloride and Guaifenesin., Indian Journal of Pharmaceutical Sciences, 2011; 3(2).
21. Useni Reddy Mallui, Varaprasad Bobbarala and Somasekhar Penumajji., Analysis of Cough and Analgesic Range of Pharmaceutical Active Ingredients Using RP-HPLC Method., International Journal of Pharma and Biosciences,2011; 2(3):439-452.
22. Sandhya N Kumar, M.P. Kavitha, K. Krishna Kumar, Review on Chromatographic Methods for the Simultaneous Estimation of Bromohexine Hydrochloride and Salbutamol Sulphate, Asian Journal of Research in Chemistry and Pharmaceutical Sciences. 2017; 5(1): 33-37.
23. Senthil raja M And GiriRaj P,, Reverse phase HPLC Method for the Simultaneous Estimation of Terbutanile Sulphate ,Bromhexine and Guaifenesin in cough syrup., Asian Journal of Pharmaceutical and Clinical Research, 2011; 4(2).
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