Volume : 12, Issue : 01, January – 2025
Title:
ANALYTICAL METHOD DEVELOPMENT & VALIDATION OF DICYCLOMINE HCL AND PARACETAMOL BY RP-HPLC
Authors :
Gannoju Vasundhara, Koppu Udaya Bhanu Sri*, Dr.D. Venkata Ramana, Dr. G. Sai Kiran.
Abstract :
An analytical method for the simultaneous estimation of Dicyclomine Hydrochloride (HCL) and Paracetamol in pharmaceutical dosage forms was developed and validated using Reverse Phase High-Performance Liquid Chromatography (RP-HPLC). The method was optimized to ensure efficient separation and accurate quantification of both drugs. The Waters HPLC system equipped with an auto-sampler and PDA Detector 996 model was used, employing a Phenomenex Gemini C18 column (4.6 mm × 150 mm, 5.0 µm particle size). The mobile phase consisted of methanol and TEA buffer (pH 4.8) in a 32:68 (v/v) ratio, and the column temperature was maintained at 38˚C. The method utilized a flow rate of 1 mL/min and detection at a wavelength of 248 nm. The injection volume was 20 µL, and the total run time was 7 minutes. The method was validated according to ICH guidelines for parameters such as specificity, accuracy, precision, linearity, and robustness. The results demonstrated the method’s suitability for the routine analysis of Dicyclomine HCL and Paracetamol in pharmaceutical formulations, offering a fast, reliable, and cost-effective approach for quality control in the pharmaceutical industry.
Keywords: Dicyclomine Hydrochloride (HCL) and Paracetamol, RP-HPLC, Simultaneous Estimation, Pharmaceutical Dosage Forms, Waters HPLC.
Cite This Article:
Please cite this article in press Koppu Udaya Bhanu Sri et al., Analytical Method Development & Validation Of Dicyclomine Hcl And Paracetamol By RP-HPLC.,Indo Am. J. P. Sci, 2025; 12 (01).
Number of Downloads : 10
References:
1. Meyer V.R. Practical High-Performance Liquid Chromatography, 4th Ed. England, John Wiley & Sons Ltd, (2004), PP 7-8.
2. Sahajwalla CG a new drug development, vol 141, Marcel Dekker Inc., New York, (2004), PP 421–426.
3. Introduction to Column. (Online),URL:http://amitpatel745.topcities.com/index_files/study/column care.pdf
4. Detectors used in HPLC (online )URL:http://wiki.answers.com/Q/What_detectors_are_used_in_HPLC
5. Detectors (online) ,URL:http://hplc.chem.shu.edu/NEW/HPLC_Book/Detectors/det_uvda.html
6. Dr.Kealey and P.J.Haines, Analytical Chemistry, 1stedition, Bios Publisher,(2002),PP:1-7.
7. A.BraithWait and F.J.Smith, Chromatographic Methods, 5thedition, Kluwer Academic Publisher, (1996), PP 1-2.
8. Andrea Weston and Phyllisr. Brown, HPLC Principle and Practice, 1st edition, Academic press, (1997), PP 24-37.
9. Yuri Kazakevich and Rosario Lobrutto, HPLC for Pharmaceutical Scientists, 1stedition, Wiley Interscience A JohnWiley & Sons, Inc., Publication, (2007), PP 15-23.
10. Chromatography, (online). URL:http://en.wikipedia.org/wiki/Chromatography.
11. Draft ICH Guidelines on Validation of Analytical Procedures Definitions and terminology. Federal Register, vol 60. IFPMA, Switzerland, (1995), PP 1126.
12. Code Q2B, Validation of Analytical Procedures; Methodology. ICH Harmonized Tripartite Guidelines, Geneva, Switzerland, (1996), PP 1- 8.
13. Introduction to analytical method validation (online), available from: URL: http://www.standardbase.hu/tech/HPLC%20validation%20PE.pdf.
14. Data elements required for assay validation, (online) available from: URL: http://www.labcompliance.com/tutorial/methods/default.aspx.
15. Snyder LR practical HPLC method development, 2nd edition. John Wiley and sons, New York, (1997), PP 180-182.
16. Skoog D A, West D M, Holler FJ: Introduction of analytical chemistry. Sounder college of publishing, Harcourt Brace college publishers. (1994), PP 1-5.
17. Sharma B K, Instrumental method of chemical analysis Meerut. (1999), PP 175-203.
18. Willard, H. y. Merritt L.L, Dean J.A and Settle F.A “Instrumental methods of analysis” 7th edition CBS publisher and distributors, New Delhi, (1991), PP 436-439.
19. ICH Q2A, “Validation of analytical methods, definitions and terminology”, ICH Harmonized tripartite guideline, (1999).
20. Kumar A, Chawla P, Porwal P, Rawal RK and Anghore D. Development and Validation of Mefenamic Acid, Dicyclomine HCl and Pamabrom in Marketed Formulation by HPLC. Pharm Anal Acta 2018, 9:9.
21. Esha Khadge, Savita Yadav, Jahnavi Rao. Reversed Phase High Performance Liquid Chromatography Method Development And Validation For Simultaneous Estimation Of Dicyclomine Hydrochloride, Paracetamol And Mefenamic Acid In Bulk And Tablet Dosage Form. Asian J Pharm Clin Res, Vol 10, Issue 3, 2017.
22. Hemraj Sharma , Kammili Vishakha, Kondreddy Vinod Kumar and Hari Prasad Bhatta. Validated Rp-Hplc Method For Simultaneous Estimation Of Paracetamol, Pamabrom And Dicyclomine, Hydrochloride In Bulk And Pharmaceutical Dosage Form. IJPSR, 2016; Vol. 7(1): 316-324.
23. Hanumant Gaikwad, Sachin Borde, Manjula Suralkar, Vishnu Choudhari and Bhanudas Kuchekar. Development and Validation of RP-HPLC Method for Simultaneous Determination of Tramadol hydro chloride, Paracetamol and Dicyclomine hydro chloride. International Journal of Pharma Sciences Vol. 4, No. 6 (2014).
24. Shah DA, Rana JP, Chhalotiya UK, Baldania SL, Bhatt KK. Development and validation of a liquid chromatographic method for estimation of dicyclomine hydrochloride, mefenamic Acid and paracetamol in tablets. Indian J Pharm Sci. 2014 Nov-Dec;76(6):529-34.