title: Development and validation of RP HPLC method to determine nandrolone phenylpropionate in different pharmaceutical formulations.
abstract: This study describes development and subsequent validation of a reversed phase high performance liquid chromatographic (RP-HPLC) method for the estimation of nandrolone phenylpropionate, an anabolic steroid, in bulk drug, in conventional parenteral dosage formulation and in prepared nanoparticle dosage form. The chromatographic system consisted of a Luna Phenomenex, CN (250 mm x 4.6 mm, 5 microm) column, an isocratic mobile phase comprising 10 mM phosphate buffer and acetonitrile (50:50, v/v) and UV detection at 240 nm. Nandrolone phenylpropionate was eluted about 6.3 min with no interfering peaks of excipients used for the preparation of dosage forms. The method was linear over the range from 0.050 to 25 microg/mL in raw drug (r2 = 0.9994). The intra-day and inter-day precision values were in the range of 0.219-0.609% and 0.441-0.875%, respectively. Limits of detection and quantitation were 0.010 microg/mL and 0.050 microg/mL, respectively. The results were validated according to International Conference on Harmonization (ICH) guidelines in parenteral and prepared nanoparticle formulation. The validated HPLC method is simple, sensitive, precise, accurate and reproducible.
authors.affiliation: Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700 032, India.
authors.forename: Jayanti
authors.initials: J
authors.lastname: Mukherjee
authors.forename: Ayan
authors.initials: A
authors.lastname: Das
authors.forename: Uday Sankar
authors.initials: US
authors.lastname: Chakrabarty
authors.forename: Bijay Kumar
authors.initials: BK
authors.lastname: Sahoo
authors.forename: Goutam
authors.initials: G
authors.lastname: Dey
authors.forename: Hira
authors.initials: H
authors.lastname: Choudhury
authors.forename: Tapan Kumar
authors.initials: TK
authors.lastname: Pal
mesh_terms: D045930:Anabolic Agents / Q000032:analysis*; D002021:Buffers; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000592:standards; D056148:Chromatography, Reverse-Phase / Q000592:standards; D004304:Dosage Forms; D004339:Drug Compounding; D007267:Injections; D009277:Nandrolone / Q000031:analogs & derivatives* / Q000032:analysis; D053758:Nanoparticles; D015588:Observer Variation; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
chemical_list: D045930:Anabolic Agents; D002021:Buffers; D004304:Dosage Forms; D009277:Nandrolone; C008580:nandrolone phenpropionate