Development of a validated RP-LC/ESI-MS-MS method for separation, identification and determination of related substances of tamsulosin in bulk drugs and formulations.
A reversed-phase high performance liquid chromatographic (RP-HPLC) method for evaluation of purity of tamsulosin in bulk drugs and pharmaceuticals was developed. The separation was accomplished on an Inertsil C(18) column using 10 mM ammonium acetate: acetonitrile as a mobile phase in a gradient elution mode. A photodiode array detector set at 280 nm was used for detection. The impurities were identified by ESI-MS-MS. The detection limits were 0.06-0.11 microg/ml. The method was validated with respect to accuracy, precision, linearity, ruggedness and limits of detection and quantification. It finds application not only for monitoring the reactions during the process development but also on quality assurance of tamsulosin.
Nageswara Rao
R
R
Analytical Chemistry Division, Discovery Laboratory, Indian Institute of Chemical Technology, Tarnaka, Hyderabad 500007, India. rnrao55@yahoo.com
Kumar Talluri
M V N
MV
Narasa Raju
A
A
Shinde
Dhananjay D
DD
Ramanjaneyulu
G S
GS
D002021:Buffers; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D004340:Drug Contamination / Q000517:prevention & control; D004345:Drug Industry / Q000295:instrumentation / Q000379:methods; D006863:Hydrogen-Ion Concentration; D015394:Molecular Structure; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000737:chemistry / Q000302:isolation & purification; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000295:instrumentation / Q000379:methods*; D013449:Sulfonamides / Q000032:analysis* / Q000737:chemistry / Q000302:isolation & purification; D000077409:Tamsulosin; D053719:Tandem Mass Spectrometry / Q000295:instrumentation / Q000379:methods*; D013696:Temperature
D002021:Buffers; D004364:Pharmaceutical Preparations; D013449:Sulfonamides; D000077409:Tamsulosin