Development and Validation of a Simple and Sensitive Spectrometric Method for Estimation of Cisplatin Hydrochloride in Tablet Dosage Forms: Application to Dissolution Studies

Cisplatin hydrochloride is an important chemotherapeutic drug for cancer treatment. It has a low molar absorptivity in the UV region and has no fluorescence. Therefore, a selective derivatizing reaction is required for its detection in bulk and pharmaceutical dosage form if detection by UV spectrophotometry is sought. In view of this, a simple, accurate, rapid, and cost-effective spectrophotometric method for its estimation has been developed by the complexation of the drug with ortho-phenylene diamine and monitoring the absorbance of formed green color at 706 nm. The method has been validated and successfully applied for the assay and dissolution studies of cisplatin hydrochloride tablets. The method demonstrated good linearity over the range from 0.4 to 1.4 μg/mL with a correlation coefficient of 0.9999. The accuracy of the method was 99.98%. The precision demonstrated relative standard deviation of less than 2.5%. The developed method was successfully applied for dissolution studies of sustained release tablets of cisplatin with a cumulative release of 86.7% in 12 hours. The proposed method can be applied in routine quality control in the pharmaceutical industries since it is precise, accurate, simple, and economic.

[1]  K. Hanada,et al.  Quantitative determination of unchanged cisplatin in rat kidney and liver by high-performance liquid chromatography. , 1995, Journal of chromatography. B, Biomedical applications.

[2]  K. Inagaki,et al.  Direct determination of cis-dichlorodiammineplatinum(II) in urine by derivative spectroscopy. , 1985, Chemical & pharmaceutical bulletin.

[3]  F. S. Rojas,et al.  Analytical methodologies for the determination of cisplatin. , 2008, Journal of pharmaceutical and biomedical analysis.

[4]  G. Yalcin,et al.  THE SPECTROPHOTOMETRIC DETERMINATION OF CISPLATIN IN URINE, USING o-PHENYLENEDIAMINE AS DERIVATIZING AGENT , 2001 .

[5]  H. Ehrsson,et al.  Determination of cisplatin and cis-diammineaquachloroplatinum(II) ion by liquid chromatography using post-column derivatization with diethyldithiocarbamate. , 1994, Journal of chromatography.

[6]  J. Fagerberg,et al.  Pharmacokinetics of cisplatin and its monohydrated complex in humans. , 1996, Journal of pharmaceutical sciences.

[7]  J. Schellens,et al.  Validated method for the determination of platinum from a liposomal source (SPI-77) in human plasma using graphite furnace Zeeman atomic absorption spectrometry , 2000, Fresenius' journal of analytical chemistry.

[8]  R. Kizu,et al.  A method for determining cis-dichlorodiammineplatinum(II) in plasma and urine by high performance liquid chromatography with direct ultraviolet detection. , 1985, Chemical & pharmaceutical bulletin.

[9]  R. W. Frei,et al.  Quantitative determination of cisplatin in body fluids by liquid chromatography with quenched phosphorescence detection. , 1987, Journal of pharmaceutical and biomedical analysis.

[10]  M. Macka,et al.  Separation of some platinum(II) complexes by ionic strength gradient on a solvent-generated ion-exchange sorbent. , 1991, Journal of chromatography.

[11]  G. G. Stokes "J." , 1890, The New Yale Book of Quotations.

[12]  G. H. Ayres,et al.  Spectrophotometric determination of platinum with o-phenylenediamine. , 1973, Talanta.

[13]  R. Kizu,et al.  A sensitive postcolumn derivatization/UV detection system for HPLC determination of antitumor divalent and quadrivalent platinum complexes. , 1995, Chemical & pharmaceutical bulletin.

[14]  A J Thomson,et al.  The inhibition of growth or cell division in Escherichia coli by different ionic species of platinum(IV) complexes. , 1967, The Journal of biological chemistry.

[15]  M. Y. Khuhawar,et al.  High-performance liquid chromatographic determination of cisplatin as platinum(II) in a pharmaceutical preparation and blood samples of cancer patients. , 1997, Journal of chromatography. B, Biomedical sciences and applications.

[16]  W. van der Vijgh,et al.  Simultaneous determination of intact cisplatin and its metabolite monohydrated cisplatin in human plasma. , 2002, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[17]  L. Gahan,et al.  Development of HPLC conditions for valid determination of hydrolysis products of cisplatin. , 1999, Journal of pharmaceutical sciences.

[18]  Z. Ding,et al.  High performance liquid chromatographic determination of platinum in blood and urine samples of cancer patients after administration of cisplatin drug using solvent extraction and N,N'-bis(salicylidene)-1,2-propanediamine as complexation reagent. , 2006, Journal of pharmaceutical and biomedical analysis.

[19]  René Kizek,et al.  Cisplatin electrochemical biosensor , 2006 .

[20]  W. Marsden I and J , 2012 .

[21]  R Raghavan,et al.  Low-Level (PPB) Determination of Cisplatin in Cleaning Validation (Rinse Water) Samples. I. An Atomic Absorption Spectrophotometric Method , 2000, Drug development and industrial pharmacy.