DEVELOPMENT AND VALIDATION OF LC-MS/MS METHOD FOR THE ESTIMATION OF ACRIVASTINE IN PHARMACEUTICAL DOSAGE FORM .
Â The objective of this study was to validate a simple, specific, accurate and precise solid phase high performance liquid chromatographic method with tandem mass spectrometry method for the determination of acrivastine (AC) in human plasma using pirfenidone as internal standard (ISTD). The precision and accuracy data have to fulfill the requirements for quantification of the analytes in biological matrices to generate data for bioequivalence and bioavailability investigations. A peerless basic C18, 5 Î¼ column having 4.6 mmÃ—100 mm internal diameter in binary gradient mode with flow rate was 0.8 mL/minutes of mobile phase containing methanol and 2 mm ammonium formate were used. The chromatographic separation was achieved by using elution solution consisting of methanol and 2 mm ammonium formate (70:30%, v/v)], diluent solution of methanol and water (50:50%, v/v)] were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring mode. The method was validated over the concentration range 0.5-205.170 ng/mL. Limit of detection and limit of quantification were found 0.18 ng and 0.536 ng, respectively. The retention time for AC and ISTD were 2 minutes and 2.4 minutes respectively and overall chromatography run time was 3.2 minutes. The mean recovery of AC (100.0%) and ISTD (102.5%) from spiked plasma samples was consistent and reproducible. The method was validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. The intra- and inter-day precision and accuracy values were found to be within the assay variability limits as per the food and drug administration guidelines.
Keywords: Acrivastine, Pirfenidone, Liquid chromatography tandem mass spectrometer, Linearity, Validation.Â
Onur F, Palabiyik IM, Dinc E. Liquid chromatographic and spectrophotometric determination of triprolidine hydrochloride, acrivastine and pseudoephedrine hydrochloride in pharmaceutical preparations and human plasma. Anal Chem 2006;2(5-6):199-211.
FernÃ¡ndez Torres R, CallejÃ³n MochÃ³n M, JimÃ©nez SÃ¡nchez JC, Bello LÃ³pez MA, GuiraÃºm Perez A. Electrochemical behaviour and determination of acrivastine in pharmaceuticals and human urine. J Pharm Biomed Anal 2002;30:1215-22.
Badawey AM, Abbas SS, Loutfy HM. Spectrophotometric determination of some antihistaminic drugs using 7,7,8,8-tetracyanoquinodimethane (TCNQ). J AOAC Int 2006;89(1):46-52.
Gazy AA, Mahgoub H, El-Yazbi FA, El-Sayed MA, Youssef RM. Determination of some histamine H1-receptor antagonists in dosage forms. J Pharm Biomed Anal 2002;30:859-67.
Collins BR, Gu X. Quantification of antihistamine acrivastine in plasma by solid-phase extraction and high-performance liquid chromatography. J Pharm Biomed Anal 2007;43(1):293-7.
Altuntas TG, Zanooz SS, Nebioglu D. Quantitative determination of acrivastine and pseudoephedrine hydrochloride in pharmaceutical formulation by high performance liquid chromatography and derivative spectrophotometry. J Pharm Biomed Anal 1998;17(1):103-9.
X Gu, MacNair KR, Simons KJ, Simons FE. Simultaneous analysis of H1-antihistamine acrivastine and the decongestant pseudoephedrine hydrochloride by high performance liquid chromatography. J Pharm Biomed Anal 2005;37(4):663-7.
Abdine H, Belal F. Polarographic behaviour and determination of acrivastine in capsules and human urine. Talanta 2002;56(1):97-104.
Ajitha A, Thenmozhi A, Sridharan D, Rajamanickam V, Palanivelu M. Rapid and sensitive LC-MS/MS for the simultaneous estimation of amoxicillin and clavulanic acid in human plasma. Asian J Pharm Clin Res 2010;3(2):106-9.
Reddy S, Ahmad I, Nayak N, Thangam S, Mukhopadhyay A. Estimation of nifedipine in human plasma by LC-MS/MS. Asian J Pharm Clin Res 2013;6(1):83-6.
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