DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL AND TAPENTADOL HYDROCHLORIDE IN TABLET DOSAGE FORM

A simple, precise, accurate and reproducible spectrophotometric method has been developed forSimultaneous estimation of Paracetamol and Tapentadol Hydrochloride by employing first order derivativezero crossing method in 0.1 N Sodium Hydroxide. The first order derivative absorption at 257.1 nm (zerocross point of Paracetamol) was used for quantification of Tapentadol HCl and 289.0 nm (zero cross point ofTapentadol HCl) for quantification of Paracetamol. The linearity was established over the concentrationrange of 15-3

Quantitative determination of ciprofloxacin residues for cleaning validation in manufacturing equipment surface

233-237In this study, UV spectroscopic and total organic carbon (TOC) Vcsh methods have been developed and validated for the determination of trace amount of ciprofloxacin residues on the manufacturing equipment surfaces and <span style="mso-fareast-font-family: Calibri;mso-bidi-font-weight:bold" lang="EN-GB">to confirm the efficiency of the cleaning procedure. Ciprofloxacin has been selected on the basis of worst case rating approach. The established limit of contamination value for ciprofloxacin is found to be 36.27 µg that should not be exceeded during consecutive equipment cleaning trials. Ciprofloxacin exhibits good linearity in the range <span style="mso-fareast-font-family:Calibri; mso-bidi-font-weight:bold" lang="EN-GB">2-10 µg/mL for UV spectroscopic<span style="mso-fareast-font-family:Calibri; mso-bidi-font-weight:bold" lang="EN-GB"> method and 0.25-1.5 µg/mL for <span style="mso-fareast-font-family:Calibri;mso-bidi-font-weight: bold" lang="EN-GB">TOC Vcsh analysis. <span style="mso-fareast-font-family:Calibri; mso-bidi-font-weight:bold" lang="EN-GB">Percentage recovery from spiked stainless steel plate using swab sampling technique is found in the limit of 90.74% and 91.19 % in UV spectroscopic and TOC Vcsh method respectively. Both methods are<span style="mso-bidi-language: GU" lang="EN-GB"> simple, cheap and less time consuming as well as suitable for quantitative determination of ciprofloxacin on manufacturing equipment surfaces well below the limit of contamination. The validated methods are found to be satisfactory for the demonstration of cleaning validation of ciprofloxacin residue on manufacturing equipment surface. </span