Development and Validation of HPLC and HPTLC Methods for Therapeutic Drug Monitoring of Capecitabine in Colorectal Cancer Patients.

Capecitabine is a prodrug of 5-fluorouracil, employed as a monotherapy or combination chemotherapy agent for treatment of colorectal cancer. Combination therapy of capecitabine consists of oxaliplatin, and hence, it becomes essential to determine that co-administration does not affect its metabolism. High-performance liquid chromatography and high-performance thin-layer chromatography methods were developed and validated to determine the plasma concentration of capecitabine. In this study, blood samples from 12 patients with colorectal cancer were collected and analyzed by both methods with a reference internal standard. Two groups consisting of six patients each were formed: the first group was treated with capecitabine monotherapy, the second group with capecitabine + oxaliplatin combination therapy. The results of analysis from both the methods indicated that there is no significant drug-drug interaction. The co-administration of oxaliplatin did not affect the metabolism of capecitabine. Both assay methods were compared for their sensitivity, robustness and specificity. It was found that both the assay methods were suitable for therapeutic drug monitoring of capecitabine.

A rapid and simple HPTLC assay for therapeutic drug monitoring of capecitabine in colorectal cancer patients.

Capecitabine is a prodrug of 5-flurouracil, employed as a broad spectrum chemotherapeutic agent. It is also used as monotherapy or a combination chemotherapy agent for the treatment of colorectal cancer. Capecitabine is administered in combination with oxaliplatin and hence it is essential to determine that co-administration does not affect its metabolism. To determine the plasma concentration of capecitabine a simple HPTLC method was developed and validated. Blood samples from 12 patients with colorectal cancer were collected and analyzed by the HPTLC method with a reference internal standard. Out of these 12 patients, six were treated with capecitabine monotherapy and another six were treated with capecitabine + oxaliplatin combination therapy. The results of analysis indicated that there was no significant drug-drug interaction and the co-administration of oxaliplatin did not affect the metabolism of capecitabine. This method is sensitive, robust and specific and allows analysis of multiple samples simultaneously, making it suitable for therapeutic drug monitoring of capecitabine.

Simultaneous determination of metronidazole and miconazole nitrate in gel by HPTLC.

A new, simple, precise, rapid and selective high-performance thin-layer chromatographic (HPTLC) method for the simultaneous quantification of Metronidazole (MTZ) and Miconazole nitrate (MCZ) in gel has been developed. It was performed on silica gel 60 GF254 Thin Layer Chromatographic plates using mobile phase comprising of Toluene: Chloroform: Methanol (3.0:2.0:0.6 v/v) and the detection was carried out at 240 nm using densitometer. The retention factors of MTZ and MCZ were 0.34 and 0.55 respectively. Calibration curves were linear in the range of 300-700 ng/spot of MTZ and 600-1400 ng/spot of MCZ both by height and by area. The percent recovery of the drugs from gel carried out by standard addition method was found to be 100.13+/-1.59 (by height) and 98.92+/-0.76 (by area) for MTZ and 99.49+/-1.58 (by height) and 99.63+/-1.46 (by area) for MCZ indicative of accuracy and precision of simultaneous determination of MTZ and MCZ nitrate.