International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Simultaneous Estimation of Cefuroxime Axetil and Linezolid by Three Novel Spectrophotometric Methods in Pharmaceutical Dosage Form and their Comparision Using ANOVA
Patel E J, Patel D J, Desai S A, Meshram D B
Three simple, accurate, sensitive, precise and economical UV spectrophotometric methods (A,B & C) have been developed for simultaneous estimation of cefuroxime axetil and linezolid in pharmaceutical dosage form and their comparision using ANOVA.  Method A employs solving of simultaneous equations based on the measurement of absorbance at two wavelengths, 277 nm and 257 nm which are the λmax values of cefuroxime axetil and linezolid,  respectively in methanol. Method B is based on the principle of Q- absorbance ratio where in the absorbance was measured at 272 nm (iso-absorptive point) and 257 nm (λmax of linezolid ) in methanol. The linearity was obtained in the concentration ranges of 3-11 and 3.6 – 13.2 µg/ml, respectively. Method C is based on the first derivative spectrophotometric method at zero crossing wavelengths. In this method the zero crossing point of cefuroxime axetil was selected at 256 nm and for linezolid it was 275 nm. The linearity was obtained in the concentration range of 10-30 μg/ml for cefuroxime axetil and 12-36 μg/ml for linezolid. The accuracy and precision of the methods were determined and validated statistically. All the methods showed good reproducibility and recovery with % RSD less than 2. The three methods were compared using one -way ANOVA and the fcal value was found to be less than ftab value indicating that there is no significant difference in the assay results by the three methods. All methods were found to be rapid, specific, precise and accurate and these methods  require no preliminary separation and found  no interferences from the tablet excipients so it can  be used for routine analysis of both drugs in quality control  laboratories.

2. In vitro Comparative Study of Different Brands of Dexamethasone Tablet Available in Bangladesh
Jakaria M, Mousa A Y, Parvez M, Zaman R, Arifujjaman, Sayeed M A, Ali M H
Dexamethasone, a steroidal drug belongs to synthetic member of the glucocorticoid class that produced anti-inflammatory as well as immunosuppressant effects. The aim of the present study was to comparative study of quality parameters such as weight variation test, hardness test, friability test, disintegration test, assay and acid-base degradation studies among the different brands of dexamethasone tablet available in Bangladesh. The in vitro study was done by performing various test procedures associated to assess the quality of tablets. The brands had been passed for the weight variation tests, because no tablets cross the ± 10 % weight variation. According to the test procedure by using Monsanto hardness tester, no brands of dexamethasone tablets were within the specified limit. Percentage friability of the six brands was not more than 1% and thus they met the specifications. The entire brand disintegrated within 5 minutes and thus they complied with the specifications. Except brand Dexameson, percent of assay for all brands were between ranges 90-110%. In degradation study, no brands comply with the USP specified limit that means desxamethasone was not stable in the forced degradation study. In conclusion, in the quality control parameters studies, all brands of dexamethasone tablet (except. Dexameson in assay), had shown satisfactory results.

3. Establishing a Cleaning Method Validation Programme of Solid Dosage Form of a Finished Drug Product
Md. Semimul Akhtar,Shailendra Kumar Verma
Cleaning validation proved the effectiveness of the cleaning procedures used for cleaning product contact equipment. These can be accomplished by analyzing swab and / or rinse samples for chemical residues. The approach evaluates overall cleaning requirement of the product range and concentrates the validation effort to develop ‘Worst Case’ situation, where common cleaning procedures are followed for similar type (Operating Principle and Capacity) of equipment Rationale for the residue limit established should be scientific, logical and based upon knowledge of the material. As per the guide to inspections of Validation of Cleaning Processes the limits should be “practical, achievable and verifiable”. The limit is often based on allowing not more than a fraction of a therapeutic dose to be present in a subsequent product. The fraction in this case is called as a “Safety factor”. The degree of risk may be different for different dosage forms. The final conclusion has been drawn on the basis of the results obtained during execution of the cleaning validation on solid dosage forms. Altogether three consecutive batches of Librium 10 Tablets (Clordiazepoxide 10 mg) were taken under cleaning validation study to prove the effectiveness and consistency of the pre-established standard equipment cleaning procedures. All the results were evaluated against the acceptance criteria mentioned in Cleaning Validation Master Plan, i.e. NMT 10 ppm and NMT 100 ppm for residue limits of direct contact surfaces and non contact surfaces.

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