ANALYTICAL QUALITY BY DESIGN APPROACH FOR DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHODS IN THE ESTIMATION OF TROSPIUM CHLORIDE FROM CAPSULE DOSAGE FORM
Keywords:Quality by Design (QbD), Trospium chloride, UV Spectrophotometry, ICH Q8 (R2), Principal component analysis
Objective: The aim of present work is to develop and validate two spectrophotometric methods for trospium chloride estimation in capsule dosage form using Analytical Quality by Design (QbD) approach as per ICH Q8 (R2) guidelines.
Methods: Variable parameters like type of sample preparation, solvent, wavelength, instrumental parameters such as slit width, scan speed and sampling interval etc. were designed into Ishikawa diagram and critical parameters were determined by observation as well as by using principal component analysis.
Results: In simple spectrophotometric method, trospium chloride was estimated at 258 nm using 0.1 N sodium hydroxide. Beer's law was obeyed in the concentration range 200-1000 Î¼g/ml (r2 = 0.999). In first derivative spectrophotometric method, beer's law was obeyed in concentration range 20-100 Î¼g/ml (r2 = 0.999) at 226.6 nm using 0.1 N sodium hydroxide. The proposed methods were validated according to ICH Q2 (R1) analytical method validation guidelines.
Conclusion: The proposed methods were found to be accurate, precise, and economical and can be applicable for routine quality control analysis of trospium chloride on pharmaceutical dosage form. Implementation of QbD approach resulted in more robust methods which can produce consistent, reliable, and quality data throughout the process and also save time and money.
P Borman, et al. The application of quality by design to analytical methods. Pharmtech 2007;1(2):177â€“83.
M Pohl, M Schweitzer, G Hansen. Implications and opportunities of applying the principles of QbD to analytical measurements.â€ Pharm Technol Eur 2010;22(2):29â€“36.
British Pharmacopoeia 2012, British pharmacopeia commission, The department of health, social services and public safety: published by The Stationary Office, London; 2012;2:2237.
Langguth P, Kubis A, Krumbiegel G, Lang W, Merkle HP, Wachter W. Intestinal absorption of the quaternary trospium chloride: permeability-lowering factors and bioavailabilities for oral dosage forms. Eur J Pharm Biopharm 1997;43(3):265â€“72.
Knopp SB, Rietbrock S, Weyhenmeyer R, Bocker RH, Beckurts KT, Lang W, et al. Inhibitory effects of trospium chloride on cytochrome p450 enzymes in human liver microsomes. Pharmocol Toxicol 1999;85:299-304.
Hotha KK, Bharathi V, Kumar SS, Reddy YN, Chatki PK, Ravindranath LK. Determination of the quaternary ammonium compound trospium in human plasma by LCâ€“MS/MS: application to a pharmacokinetic study. J Chromatogr B 2010;878(13â€“14):981â€“6.
Vijaya Lakshmi M, Rao J, Lakshmana Rao A. RP-HPLC Estimation of trospium chloride in tablet dosage forms. E-J Chem 2012;9(3):1407-11.
Tang J, Tan ZR, Zhou YB, Ding JS. High-performance liquid chromatography-tandem mass spectrometry for the determination of trospium chloride in human plasma and its application in a bioequivalence study. Anal Lett 2011;44(4):607-16.
Lin XH, Song DJ, Rong TZ, Ping YG. Determination of trospium chloride in human plasma by HPLC-MS and study on the relative bioavailability of domestic and imported preparations. Chin J Hosp Pharm 2007;04.
Hao Z, Ping LZ, Qiang YQ. Determination of trospium chloride in human plasma by LC-MS/MS. Food Drug 2009;11.
Keil GS, Spahn H, Mutschler E. Fluorimetric determination of the quaternary compound trospium and its metabolite in biological material after derivatization with benoxaprofen chloride. J Chromatogr B Biomed Sci Appl 1985;345:99â€“110.
Bendale AR, Prajapati V, Narkhede SP, Jadhav AG, Vidyasagar G. Analytical method development & validation protocol for trospium chloride in tablet dosage form. Indo-Global J Pharm Sci 2011;1(2):166-72.
Panda SS, Ravi Kumar VV, Mohanta G, Dash R, Patel PK. New stability indicating RP-UFLC method for determination of trospium chloride in tablet dosage form. Sci Pharm 2012;80(4):955â€“64.
ICH Topic Q8 (R2). ICH harmonised tripartite guideline, International Conference on Harmonisation of technical Requirements for registration of pharmaceuticals for human use, Pharmaceutical development; 2009.
ICH Topic Q2 (R1). ICH harmonised tripartite guideline, International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use, Validation of Analytical Procedures; 1994.