Development and Validation of the UV-Spectrophotometric Method for Determination of Terbinafine Hydrochloride in Bulk and in Formulation.

Development and validation of the UV-spectrophotometric method for determination of terbinafine hydrochloride in bulk and in formulation.

Pharm Methods. 2011 Jul; 2(3): 198-202
Jain PS, Chaudhari AJ, Patel SA, Patel ZN, Patel DT

The main objective was to develop and validate the UV-spectrophotometric method for the estimation of terbinafine hydrochloride in bulk and pharmaceutical formulations as per ICH guidelines.A simple, rapid, accurate, and economical UV-spectrophotometric method has been developed for the estimation of terbinafine hydrochloride from bulk and pharmaceutical formulation.The ?max of terbinafine hydrochloride in water was found to be 283 nm. The drug follows linearity in the concentration range 5-30 ?g/ml with a correlation coefficient value of 0.999. The proposed method was applied to pharmaceutical formulation and % amount of drug. estimated was 99.19% and was found to be in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels, i.e., 80%, 100%, and 120%. The % recovery was found to be in the range of 98.54- 99.98%. The low values of % RSD are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intraday; interday variations, and repeatability. The % RSD value < 2 indicates that the method is precise. Ruggedness of the proposed method was studied with the help of two analysts.The above method was a rapid tool for routine analysis of terbinafine hydrochloride in the bulk and in the pharmaceutical dosage form. HubMed – drug

 

Spectrophotometric determination of ethacridine lactate in infusion.

Pharm Methods. 2011 Jul; 2(3): 189-92
Jain PS, Surana SJ

A simple, rapid, selective, accurate, and precise UV spectrophotometric method has been developed for the estimation of ethacridine lactate from bulk and pharmaceutical formulation.Appropriate aliquot portions of stock standard solution of ethacridine lactate were transferred into five separate 10 ml volumetric flasks, and the volume was adjusted to the mark with double distilled water to obtain concentrations of 0.2, 0.4, 0.6, 0.8, 1.0, and 1.2 ?g/ml. The ?max of ethacridine lactate in double distill water was found to be 271 nm with an apparent molar absorptivity of 59.781 × 10(3) l/mol cm. The drug follows linearity in the concentration range 2-12 ?g/ml with a correlation coefficient value of 0.998.The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 99.71% was found to be in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels, i.e., 80%, 100%, and 120%. The % recovery was found to be in the range 99.26-100.25%. The low values of % RSD are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as intraday, interday variations and repeatability. The % RSD value less than 2 indicates that the method is precise. Ruggedness of the proposed method was studied with the help of two analysts.The results indicated that the method could be used for the routine estimation of ethacridine lactate from tablet formulations. HubMed – drug

 

New spectrophotometric estimation of indomethacin capsules with niacinamide as hydrotropic solubilizing agent.

Pharm Methods. 2011 Jul; 2(3): 184-8
Maheshwari RK, Rathore A, Agrawal A, Gupta MA

Hydrotropic solubilization process involves cooperative intermolecular interaction with several balancing molecular forces, rather than either a specific complexation event or a process dominated by a medium effect, such as co-solvency or salting-in.In the present investigation, hydrotropic solution of 2 M niacinamide was employed as the solubilizing agent to solubilize the poorly water-soluble drug, indomethacin, from the capsule dosage form for spectrophotometric determination in ultraviolet region.Hydrotropic agent used did not interfere in the spectrophotometric analysis. In preliminary solubility studies, it was found that there was more than fivefold enhancement in the aqueous solubility of indomethacin (poorly water-soluble drug) in 2 M niacinamide solution as compared to its aqueous solubility at 28 ± 1°C.The proposed method is new, simple, safe, environmentally friendly, economic, accurate and cost-effective and can be successfully employed in routine analysis. HubMed – drug