Development and Validation of a Stability-indicating HPLC Technique for Measuring Temozolomide in its pharmaceutical dose form

Using RP HPLC, an accurate and precise technique for the measurement of Temozolomide in its pharmaceutical dose form was developed and validated. Chromatographic separation was achieved on an X Terra RP 18(250mm x 4.6mm), 5 mu column using a mobile phase consisting of methanol and buffer in the ratio of 10:990v/v. The flow rate was 1mL/min with the detection wavelength of 254nm and retention time was found to be 20 minute. The developed method was validated according to ICH guidelines. With a correlation coefficient of 0.9990, linearity was observed in the range of 50-150 percent. The %RSD of the developed method for precision and Intermediate precision was found to be 0.65% and 0.59% respectively. With a percent recovery of 99.82 +/- 0.045, the approach was confirmed to be reliable. All of the validation parameters yielded results that were within acceptable limits. It was discovered that the procedure was accurate, exact, specific, rugged, and durable. As a result, the newly discovered approach can be used for finish product of quality control arid stability testing on a regular basis and it has been confirmed to be stable for Temozolomide is available in both pure and pharmaceutical dose forms.