Manufacturing of Pharmaceutical products shall demonstrate a control to reproduce consistently the desired quality of product, wherein the control of cross-contamination plays an important role. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels. Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. In this article cleaning validation and cleaning validation program discussed in brief.

The present work describes a reverse phase high performance liquid chromatographic method (RP-HPLC) for the simultaneous estimation of Flupentixol and Melitracen in bulk and in tablet dosage form. Chromatographic separation was performed on Hypersil (C18) (250mm x 4.6mm, 5µm) Column, with a mobile phase comprising of a mixture of methanol and Acetonitrile in the ratio of 34:66v/v. The flow rate was 1.0ml/min with detection at 257nm. Retention times of Flupentixol and Melitracen were found to be 1.791min and 3.465min respectively. As per International Conference on Harmonization (ICH) guidelines the method was validated for linearity, accuracy, precision, limit of quantitation, limit of detection, and robustness. Linearity of Flupentixol was found to be in the range of 60-140µg/mL. and that for Melitracen was found to be 30-70µg/mL. The Precision (Repeatability, Intra-day and Inter-day) of the Flupentixol and Melitracen was found to be within the limits. The correlation coefficients were 0.999 and 0.999 for Flupentixol and Melitracen respectively. The mean recoveries obtained for Flupentixol and Melitracen were 100.28% and 99.79%. This demonstrates that the developed method is simple, precise, accurate, reproducible and rapid for simultaneous estimation of these drugs in bulk and in tablet dosage forms.