Simultaneous RP-HPLC and HPTLC estimation of fluoxetine hydrochloride and olanzapine in tablet dosage forms

Abstract

A binary mixture of fluoxetine HCl and olanzapine was determined by two different methods. The first method involved determination of fluoxetine HCl and olanzapine using reversed-phase liquid chromatography using acetonitrile:methanol:0.032 M ammonium acetate buffer (45:05:50, v/v/v) as the mobile phase at a flow rate of 1.5 ml/min. Quantitation was achieved with ultraviolet detection at 235 nm over concentration ranges of 0.2-4 and 0.1-2 μg/ml; mean accuracies were 101.16±0.59 and 99.79±0.56% for fluoxetine HCL and olanzapine, respectively. The second method was based on the high performance thin layer chromatography separation of the two drugs followed by densitometric measurements of their spots at 235 nm. The separation was carried out on Merck TLC aluminium sheets of silica gel 60 F254 using acetone:methanol:triethyleamine (5:3:0.5, v/v/v), as mobile phase. The linearity was found to be in the range of 300–1000 and 150–500 ng/spot; mean accuracies were 100.95±0.52 and 99.31±0.51% for fluoxetine HCl and olanzapine, respectively. The method was successively applied to tablets because no chromatographic interferences from the tablet excipients were found. The methods retained their accuracy and precision when the standard addition technique was applied. The results obtained by applying the proposed methods were statistically analyzed.

Determinação simultânea de olanzapina e cloridrato de fluoxetina em formulações farmacêuticas por espectrofotometria derivativa

“…Os resultados do ensaio de exatidão, realizado em três níveis de concentração e em triplicata, utilizando comprimidos manipulados (Tabela 4), revelaram que todos os métodos apresentam recuperações dentro da faixa estabelecida pela ANVISA (80-120%), 21 no entanto, o melhor método para análise do cloridrato de fluoxetina é o 2D (239,5 nm) pelo ratio spectra, onde as recuperações variaram entre 99 a 103%, e para olanzapina é o método 3D (318,5 nm) com recuperações na faixa entre 99 a 100%, sendo comparáveis aos resultados obtidos por outros autores 4,17,18 que utilizaram a técnica de cromatografia líquida de alta eficiência.…”

“…12 Para análise do cloridrato de fluoxetina há vários trabalhos que apresentam métodos usando espectrofotometria nas regiões do UV 1 e visível com formação de complexos, 13,14 técnicas eletroquímicas, 15 turbidimétricas 16 e cromatografia líquida de alta eficiência (CLAE) para sua determinação em medicamentos, sendo esta última a técnica oficial apresentada nas Farmacopeias Americana e Brasileira. 1 Para análise dos fármacos em formulações farmacêuticas contendo a combinação olanzapina e cloridrato de fluoxetina a técnica empregada é CLAE, 4,17,18 que apresenta alguns inconvenientes como o uso de equipamentos caros e procedimentos complexos, o que torna o método pouco acessível e, em alguns casos, inviáveis.…”

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC AND SPECTROPHOTOMETRY FOR SIMULTANEOUS ESTIMATION OF SILDENAFIL CITRATE AND FLUOXETINE IN BULK & TABLET DOSAGE FORM.

“…The literature survey revealed spectroscopic [5][6][7][8][9][10][11][12] and chromatographic [13][14][15][16][17][18] methods.…”

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“…A survey of literature revealed that spectrophotometric 3,4 , spectrofluorimetric 5,6 , electrochemical 7 , gas chromatography 8 , liquid chromatography [9][10][11] , capillary zone electrophoresis (CZE) 12 methods for determination of FH from pharmaceutical formulation and spectrophotometric [13][14][15][16][17] , linear voltametric 16 , HPLC [16][17][18] , CZE 18 methods for determination of OZ from pharmaceutical dosage form whereas HPLC [19][20][21][22] and HPTLC 21,22 methods for the simultaneous determination of FH and OZ from combined dosage forms were reported.…”