Validated HPTLC Method for Simultaneous Estimation of Diclofenac Sodium and Misoprostol in Bulk Drug and Formulation
Journal Title: Asian Journal of Pharmaceutical and Biological Research - Year 2011, Vol 1, Issue 1
Abstract
Objective: This present study reports for the first time simultaneous quantitation of Diclofenac Sodium and Misoprostol by HPTLC in bulk drug and in tablet dosage form. Methods: Chromatographic separation of the drugs were performed on aluminum plates precoated with silica gel 60 F as the stationary phase and the solvent system consisted of toluene:ethyl acetate:ethanol:glacial acetic acid (8:2:1:0.1) (v/v/v/v). Densitometric evaluation of the separated zones was performed at 220 nm. Results: The two drugs were satisfactorily resolved with R 254 values 0.43 ±0.02 and 0.52 ± 0.02 for Diclofenac Sodium and Misoprostol, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (40-240 ng/spot for Diclofenac Sodium and 8-48 ng/spot for Misoprostol),precision (intra-day RSD 0.94–1.58 % and inter-day RSD 1.14–1.83 % for Diclofenac Sodium, and intra-day RSD0.67–1.03 % and inter-day RSD 0.49–1.18 % for Misoprostol), accuracy (99.66 ± 0.14 % for Diclofenac Sodium and 99.52 ± 0.39 % for Misoprostol), and specificity, in accordance with ICH guidelines.Conclusion: The developed TLC technique is precise, specific and accurate. Statistical analysis proves that the method is suitable for the analysis of Diclofenac Sodium and Misoprostol as bulk drug and in pharmaceutical formulation without any interference from the excipients. It was concluded that the developed method offered several advantages such as rapid, cost effective, simple mobile phase and sample preparation steps and improved sensitivity made it specific, reliable and easily reproducible in any quality control set-up providing all the parameters are followed accurately for its intended use.
Authors and Affiliations
Sunil R. Dhaneshwar , Vidhya K. Bhusari
Keywords
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Validated HPTLC Method for Simultaneous Estimation of Diclofenac Sodium and Misoprostol in Bulk Drug and Formulation
Objective: This present study reports for the first time simultaneous quantitation of Diclofenac Sodium and Misoprostol by HPTLC in bulk drug and in tablet dosage form. Methods: Chromatographic separation of the drugs...