Rapid, Simple and Validated Method for Estimation of Zolpidem by UPLC in Tablet Dosage Form

Aim: To create and approve a novel and fast RP-UPLC technique for the estimation of zolpidem in tablet dosage form.

Place and Duration of Study: Department of pharmaceutical analysis, S.V.S. school of Pharmacy, Bheemaram, between January 2013 and May 2013.

Methodology: Chromatographic division was accomplished on a Waters Acquity HSS T-3 C18 stationary phase (100 × 2.1 mm, 1.8 μm) utilizing an isocratic technique with versatile mobile phase made out of Potassium di-hydrogen phosphate: Acetonitrile in the proportion 40:60 v/v at a stream rate of 1 mL/min. The temperature was kept constant and detection was made at 243 nm. The run time was as short as 6 min. The proposed method was validated according to the International Conference on Harmonization (ICH) rules for parameters such as linearity, precision, accuracy, specificity and robustness etc.

Results: The developed method was linear for zolpidem from 30-70 μg/ml and the linear regression obtained was > 0.999. Precision, established by intra- and inter-day assays shown relative standard deviation (R.S.D) values within 1.5%. Recovery data were in the range 99.8% to 101.4% with R.S.D. values < 1.5%.

Conclusion: The proposed method satisfied all the validation parameters prescribed by ICH. The ultra fast analysis with RT 2.754 min renders the analysis of a bulk samples in a less time and, therefore, should be cost effective for everyday analysis in the estimation of Zolpidem.