validation.

The transfer of analytical procedure (TAP), also referred to as method transfer, is the documented process that qualifies a laboratory (the receiving unit) to use an analytical test procedure that originated in another laboratory (the transferring unit), thus ensuring that the receiving unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended. Method Transfer enables to adapt method to new facility or instrument and to meet new facility validation requirements and also helps to maintain validated state of method. It gives documented guidance in principle and provides general recommendations on the necessary activities that should be addressed to conduct a successful intra- or inter- site transfer. It applies to all dosage forms such as sterile products, metered-dose aerosols and clinical trial supplies. There are many approaches to Method Transfer such as Comparative Testing, Co-validation between two laboratories, Revalidation, Transfer waiver.

A simple, rapid and precise Reverse Phase High Performance Liquid Chromatographic method was developed for simultaneous estimation of Eperisone hydrochloride and Diclofenac sodium in pharmaceutical dosage form by reverse phase Pinnacle DB C-18 column (250 mm, 4.6 mm, and 5 μm). The sample was analyzed using 50mM ammonium acetate buffer containing 0.2% triethylamine (pH-4.0 adjusted with glacial acetic acid): Acetonitrile (40:60, v/v), as a mobile phase at a flow rate of 1.0 ml/min. and detection at 273 nm. The retention time for Eperisone hydrochloride and Diclofenac sodium was found to be 3.07 min and 5.56 min, respectively. The linearity of developed method was achieved in the range of 10-100 μg/ml for Eperisone hydrochloride and 10-100 μg/ml for Diclofenac sodium. The method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation, robustness and ruggedness as per ICH guidelines.

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical second derivative spectrophotometric method for the simultaneous determination of Paracetamol and Pamabrom in dosage form. The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The second order derivative spectra were obtained in dist. water and the determinations were made at 268.2 nm (ZCP of Pamabrom) for Paracetamol and 225.0 nm (ZCP of Paracetamol) for Pamabrom. The linearity was obtained in the concentration range of 4-18 μg/ml for Paracetamol and 2-16 μg/ml for Pamabrom The method was found to be simple, sensitive, accurate and precise and was applicable for the simultaneous determination of Paracetamol and Pamabrom in pharmaceutical tablet dosage form.

A simple, selective, rapid, precise and economical reverse phase HPLC method has been developed for the determination of Metoprolol Succinate in dosage formulation. The analyte was resolved by using a mobile phase (Acetonitrile, water and 1 % ortho phosphoric acid in the ratio 70:27:3 v/v/v) at a flow rate 2.0 ml/min on an isocratic HPLC system (Agilent 1100 series with Chemstation software) consisting UV lamp detector, Aligent C-8, RP column (4.6 mm i.d x250 mm) at a wavelength of 280 nm.  The linear dynamic range for Metoprolol Succinate was 10 g/mL–200µg/mL. The limit of detection [LOD]and Limit of quantification[LOQ] for Metoprolol Succinate  was 0.0284µg/mL  and 0.094µg/mL respectively. 

Quantitative estimation of temozolamide and its pharmaceutical dosage form by UV spectroscopy, RP-HPLC, HPTLC methods was developed. In the UV method (geometric method), temozolamide was quantified at 309nm, 325nm, 340nm in serum and water. The corrected absorbance was calculated. The Recovery studies was found to be 95.5-96.9%. In RP-HPLC method, the drug was resolved using a mobile phase methanol: buffer (5.0ml glacial acetic acid in 1000ml water) (70:30%v/v) on C18 column in isocratic mode. The retention time of temozolamide was found to be 7.30 min. Recovery studies was found to be 99.55-100.98%.  In HPTLC method, the chromatograms were developed by using a mobile phase Chloroform: glacial acetic acid: methanol (2:3:5% v/v) on precoated plate of silica gel 60F254 and quantified by densiometric absorbance mode at 254nm. The Rf value of Temozolamide was 0.47. Recovery studies of 98.99-100.6%, percentage relative standard deviation (%RSD less than 2%) and correlation coefficient (linearity range) that developed methods were accurate and precise. These methods can be employed for the routine analysis of capsules containing temozolamide. Key words: Temozolamide, RP-HPLC, HPTLC, UV spectrophotometry, validation.

The present manuscript describe simple, sensitive, rapid, accurate, precise and economical first derivative spectrophotometric method for the simultaneous determination of nebivolol and hydrochlorothiazide in combined tablet dosage form. The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The first order derivative spectra were obtained in methanol and the determinations were made at 270.5 nm (ZCP of hydrochlorothiazide) for nebivolol and 282.5 nm (ZCP of nebivolol) for hydrochlorothiazide. The linearity was obtained in the concentration range of 5-100 μg/ml for nebivolol and 2-14 μg/ml for hydrochlorothiazide. The mean recovery was 100.04 + 0.93 and 99.87 + 1.16 for nebivolol and hydrochlorothiazide, respectively. The method was found to be simple, sensitive, accurate and precise and was applicable for the simultaneous determination of nebivolol and hydrochlorothiazide in pharmaceutical tablet dosage form. The results of analysis have been validated statistically and by recovery studies. Key words: Nebivolol, hydrochlorothiazide, recovery, first order derivative spectrophotometric method, tablet, validation.

  The present manuscript describe simple, sensitive, rapid, accurate, precise and economical first derivative spectrophotometric method for the simultaneous determination of nebivolol and hydrochlorothiazide in combined tablet dosage form. The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The first order derivative spectra were obtained in methanol and the determinations were made at 270.5 nm (ZCP of hydrochlorothiazide) for nebivolol and 282.5 nm (ZCP of nebivolol) for hydrochlorothiazide. The linearity was obtained in the concentration range of 5-100 μg/ml for nebivolol and 2-14 μg/ml for hydrochlorothiazide. The mean recovery was 100.04 + 0.93 and 99.87 + 1.16 for nebivolol and hydrochlorothiazide, respectively. The method was found to be simple, sensitive, accurate and precise and was applicable for the simultaneous determination of nebivolol and hydrochlorothiazide in pharmaceutical tablet dosage form. The results of analysis have been validated statistically and by recovery studies.     Key words: Nebivolol, hydrochlorothiazide, recovery, first order derivative spectrophotometric method, tablet, validation.

  The present manuscript describe simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for the simultaneous determination of Ofloxacin and Cefpodoxime proxetil in combined tablet dosage form. The method is based on the simultaneous equations for analysis of both the drugs using methanol as solvent. Ofloxacin has absorbance maxima at 297 nm and cefpodoxime proxetil has absorbance maxima at 236.2 nm in methanol. The linearity was obtained in the concentration range of 2-12 μg/ml and 4-24 μg/ml for Ofloxacin and Cefpodoxime proxetil, respectively. The concentrations of the drugs were determined by using simultaneous equations at both the wavelengths. The mean recovery was 99.63 ± 0.47 and 99.57 ± 0.36 for Ofloxacin and Cefpodoxime proxetil, respectively. The method was successfully applied to pharmaceutical dosage form because no interference from the tablet excipients was found. The suitability of this method for the quantitative determination of Ofloxacin and Cefpodoxime proxetil was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of Ofloxacin and Cefpodoxime proxetil in pharmaceutical tablet dosage form. The results of analysis have been validated statistically and by recovery studies.   Key words: Cefpodoxime proxetil, Ofloxacin, recovery, simultaneous equations method, tablet, validation.