VALIDATED CHIRAL RP-UFLC METHOD FOR THE QUANTIFICATION OF CHLORTHALIDONE IN BULK AND PHARMACEUTICAL DOSAGE FORM
Objective: Development and validation of new, simple and reliable enantioselective reverse phase ultra-fast liquid chromatography (RP-UFLC) method for quantification of chlorthalidone in bulk and pharmaceutical dosage form.
Methods: In the present study, the isocratic RP-UFLC method was developed on PhenomenexÂ® Lux cellulose 4 column (250Ã—4.6 mm, 5Âµ) and di-sodium hydrogen phosphate buffer (pH 3.6): methanol (40:60 v/v) as mobile phase. Elute was monitored at 240 nm with a flow rate of 1 ml/min.
Results: The described method provided linear correlation (R2=0.999) between the range of 2-10 Âµg/ml. Chlorthalidone enantiomers showed good resolution with a retention time (tR) of 5.75 min and 7.46 min respectively. The precision of the method revealed that relative standard deviation is within the acceptable limit. The percentage recovery of each chlorthalidone enantiomers was found to be 99.98% and 100.09% respectively. The method was validated in accordance with ICH harmonized tripartite guidelines, validation of analytical procedures: text and methodology Q2 (R1).
Conclusion: An economical, accurate, sensitive and precise RP-UFLC method was developed and fully validated for quality control analysis of chlorthalidone in pharmaceutical dosage form.
2. Walters SM, Stonys DB. Determination of chlorthalidone and clonidine hydrochloride in tablets by HPLC. J Chromatogr Sci 1983;21:43-5.
3. Barry LC, Michael EE, Jerome DC. Hydrochlorothiazide versus chlorthalidone evidence supporting their interchangeability. Hypertension 2004;43:4-9.
4. Niraimathi V, Suresh AJ, Kumar IS. UV spectrophotometric methods for the estimation of chlorthalidone in bulk and oral dosage form. Indo Am J Pharm Sci 2013;3:7160-7.
5. Jiri V, Kveta K, Eva T. Rapid supercritical fluid chromatography method for separation of chlorthalidone enantiomers. Anal Lett 2013;46:2860-9.
6. Fleuren HL, Van RJM. Determination of chlorthalidone in plasma, urine and red blood cells by gas chromatography with nitrogen detection. J Chromatogr 1978;152:41-54.
7. Brijesh S, Patel DK, Ghosh SK. A reversed-phase high-performance liquid chromatographic method for determination of chlorthalidone in a pharmaceutical formulation. Int J Pharm Pharm Sci 2009;1:24-9.
8. Naazneen S, Sridevi A. Stability-indicating rp-hplc method for the simultaneous estimation of azilsartan medoxomil and chlorthalidone in solid dosage forms. Int J Pharm Pharm Sci 2014;6:236-43.
9. Kumar GS, Ramya V, Mondal S, Sai PK. Development and validation of a RP-HPLC method for simultaneous estimation of atenolol and chlorthalidone from pharmaceutical formulation. Int Res J Pharm 2012;3:216-9.
10. Rosenberg MJ, Kathryn KL, Thomas ED. Analysis of chlorthalidone in whole blood by high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 1986;375:438-43.
11. Mohamed SE, Samia MM, Abdalla AE. Simple and rapid HPLC method for simultaneous determination of atenolol and chlorthalidone in spiked human plasma. Saudi Pharm J 2011;19:43â€“9.
12. Bijay K, Sharanjit K, Sami M, Harinder JS. First among equals: A comparative study of the effect of hydrochlorothiazide and chlorthalidone on recently diagnosed hypertensives. Asian J Pharm Clin Res 2015;8:195-8.
13. Sirisha T, Gurupadayya B, Bharath KI. Enantiomeric separation and quantitative estimation of chlorthalidone enantiomers by chiral ultra fast liquid chromatography. Int J Res Pharm Chem 2015;5:361-7.
14. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, ICH harmonized tripartite guideline validation of analytical procedures: Text and Methodology Q2 (R1), Current Step 4 version. London; 2005.