Analytical Method Development And Its Validation For Estimation Of Chlorhexidine Gluconate

In the present work, Independent method was developed for estimation of Chlorhexidine Gluconate, Metronidazole benzoate,Lignocaine Hydrochloride, and Salicylic Acid in bulk and dosage form by UV-Visible Spectrophotometry. In this method the determination ofmaximum absorbance (λmax) of the drugs were found to be 259 nm, 285.8 nm, 263 nm and 304 nm. The validation parameters were studiedaccording to ICH guidelines. On the basis of % agreement criteria, therefore Average % agreement found to be 100.05 at 259 nm, 99.32 at285.8 nm, 100.001 at 304 nm and 99.70 at 263 nm. Specificity study shows the good agreement with results, indicating that excipients did notinterfere with the analyte. Repeatability study showed a % R.S.D of 0.2486 at 259 nm, 0.2605 at 285.8 nm, 0.403174 at 304 nm and 0.880817at 263 nm for Chlorhexidine Gluconate, Metronidazole benzoate, Lignocaine Hydrochloride, and Salicylic Acid. Thus it is concluded that theanalytical technique has a good repeatability precision as R.S.D are less than 5.3% (Specified) and less than 2% (desired). So it can be said thatthe proposed method is precise. Intraday study were showed a % R.S.D of 1.246918, 0.984763, 0.775939 and 1.022045 respectively forChlorhexidine Gluconate, Metronidazole benzoate, Lignocaine Hydrochloride, and Salicylic Acid. So it can be said that the proposed method isprecise. Interday study were showed a % R.S.D of 1.358486, 0.829325, 1.273356 and 0.968196 respectively for Chlorhexidine Gluconate,Metronidazole benzoate, Lignocaine Hydrochloride, and Salicylic Acid. So it can be said that the proposed method is precise. Limit of detectionwere found to be 0.097, 0.117, 0.010 and 0.074 g/ml at 259, 285.8, 304and 263 nm. Limit of quantification were found to be 0.29, 0.35, 0.030and 0.418 g/ml at 259, 285.5 304, and 263nm. The accuracy of the methods was proved by performing recovery studies in availableformulations. Since the % recovery 98.07 to 101.28 at 259 nm, 98.29 to 101.02 at 285.8 nm, 99.99 to 101.25 at 304nm and 99.10 to 101.78 at263nm are within the desirable confidence interval of 98-102%. So it can be said that the proposed method is accurate. The percent meanrecovery is 98.46, 101.42 (1:3), 98.20 and 99.78% of labeled amount, which is within specified limits of 98-102%. It can be said that proposedmethod can satisfactory be applied for analysis of Chlorhexidine Gluconate, Metronidazole benzoate, Lignocaine Hydrochloride, and SalicylicAcid in dosage form. The developed method is precise, accurate and do not suffer from any interference due to common excipients. It isevident from this study that the developed method is simple, sensitive, specific, precise and accurate and economic. Hence it can be employedfor routine analysis in quality control laboratories.

Study on Quality Standard of Chailing Hugan Granules / 中国药房

OBJECTIVE:To establish the quality standard of Chailing hugan granules. METHODS:TLC was used for qualitative identification of Radix bupleuri,Atractylodes macrocephala and Glycyrrhiza uralensis. The content of total flavonoids (by rutin) in preparation was determined by UV-visible spectrophotometry. The moisture, dissolubility and granularity of preparation were determined. RESULTS:TLC spots of R. bupleuri ,A. macrocephala and G. uralensis were clear and well-separated without interference from negative control. The linear range of rutin was 0.050-0.300 mg/mL(r＝0.999 8). RSDs of precision, stability and reproducibility tests were all lower than 2%. The recoveries were 97.89%-100.01%(RSD＝0.68%,n＝9). The content of samples were 1.920-2.018 mg/g. The contents of moisture in 3 batches of samples were 1.54%,1.62% and 1.57%;all samples dissolved within 5 min. The sum of granules not passing through No.1 sieve and passing through No.5 sieve were 2.13%, 2.51%,2.38%,which were all in line with the requirements of Chinese Pharmacopeia (2015 edition,Vol Ⅳ). CONCLUSIONS:The content of total flavonoicle in Chailing hugan granules should be no less than 1.57 mg/g (by rutin). Established quality standard is simple,rapid,accurate and reproducible,and can be used for quality control of Chailing hugan granules.

Similarity Evaluation of the Dissolution Curves of Generic and Original Preparation of Losartan Potassium Tablets / 中国药房

OBJECTIVE:To evaluate the dissolution curves similarity of generic and original preparation of Losartan potassium tablets,and to provide reference for improving quality evaluation of the preparation.METHODS:Using hydrochloric acid solution (pH 3.0),phosphate buffer solution(pH 4.5),phosphate buffer solution (pH 6.8) and water as medium,paddle method was adopted for dissolution test with dissolution medium volume of 900 mL and rotation speed of 50 r/min.UV-visible spectrophotometry was adopted to determine accumulative dissolution of generic and original preparation of Losartan potassium tablets with the detection wavelength of 256 um.The similarity of dissolution curves were evaluated by calculating similarity factor(f2).RESULTS:The linear range of losartan potassium was 12.11-35.96 μg/mL (r≥0.999 7).RSDs of precision,stability and reproducibility tests were all lower than 5.0％.The recoveries of 4 dissolution media were 98.66％-100.84％ (RSD=0.77％,n=9),98.91％-100.59％ (RSD=0.49％,n=9),98.33％-101.39％ (RSD=0.85％,n=9),99.46％-101.32％ (RSD=0.55％,n=9).In 4 dissolution media,f2 of the dissolution curves of 3 batches of generic and original preparation of Losartan potassium tablets were all higher than 70.CONCLUSIONS:The dissolution curves of self-made and original preparation of Losartan potassium tablets show good similarity.

Preparation and Quality Control of Nicotinamide Gel / 中国药房

OBJECTIVE: To prepare Nicotinamide gel and to establish its quality control method.METHODS: Nicotinamide gel was prepared using nicotinamide as main ingredient,and the content of nicotinamide was determined by UV-visible spectrophotometry.RESULTS: Preparation was colorless gel,and its identification and test were all in conformity with the related regulation stated in Chinese Pharmacopoeia(2010 edition).The linear range of nicotinamide was 6.24～16.64 ?g?mL-1(r=0.999 5) with an average recovery rate of 102.0%(RSD=0.33%,n=5).CONCLUSION: The preparation procedure is simple and feasible,and the quality of the preparation is stable and controllable.

UV-Visible Spectrophotometric Assay for Saikosaponins in Bupleurum Chinense DC / 医学研究杂志

Objective To set up a simple and accurate method for the determination of saikosaponins in Bupleurum chinense DC. by UV-Visible Spectrophotometry. Methods The content of saikosaponins was determined by UV-Visible Spectrophotometry. The absorbency was measured at 536nm. Results The calibration curves was linear within 194~1940mg/L(r=0.9996). The average recovery was 97.35%,and the RSD was 1.02%(n=9). Conclusion The method was proved to be simple, precise and reproduciable. It can be used for the quantitative determination of B upleurum chinense DC.