Research Journal of Pharmaceutical Dosage Form and Technology

Nipanikar Madhuri ¹, Shrikrishna Baokar ¹, Undare Santosh ², R. N. Patil ¹

Affiliations
1 Department of Pharmaceutical Analysis, Shivnagar Vidya Prasarak Mandal’s College of Pharmacy, Malegaon (Bk), Tal- Baramati, Dist- Pune, Maharashtra-413115, IN
2 PG Department of Chemistry, Marathwada Shikshan Prasarak Mandal’s Balbhim Arts, Science and Commerce College, Beed, Maharashtra- 431112, IN

Abstract

Glipizide (GPZ) is chemically 1cyclohexyl3 [[p[2(5methylpyrazinecarboxamido)ethyl]phenyl] sulfonyl]urea, used in the treatment of type II diabetes mellitus. The drug is commercially available as tablets for oral administration. In the present work three simple, economical, precise and accurate UV spectrophotometrically methods have been developed for the estimation of GPZ in bulk and pharmaceutical formulation. The present method has been developed in distil 0.1 N NaOH which makes it economic and reproducible. An absorption maximum was obtained at 227 nm. The method is validated using ICH Q2R1 guideline for various parameters like precision, accuracy, etc. Drug follows linearity in concentration range 1-10 μg/ml with correlation coefficient value (r2) 0.999. The accuracy study was performed by recovery checking at three different concentrations i.e., 80%, 100% and 120 %. The % recovery was found well in limit. The precision of the method was studied as an intra-day (% R.S.D. = 0.44 %) and for inter-day (% R.S.D. = 0.22 %) variations. The % R.S.D. value less than 2 indicate that the method is precise. The proposed method is a cost-effective qualitycontrol tool for routine analysis of GPZ in pharmaceutical dosage form.

Keywords

UV-spectrophotometer, Glipizide.

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Shilpa Jagtap ¹, Smrutidevi Sonavane ², Shrikrishna Baokar ³, Vinod Pawar ⁴, R. N Patil ⁵

Affiliations
1 Department of Pharmaceutical Chemistry, Shivnagar Vidya Prasarak Mandal’s College of Pharmacy, Malegaon (Bk), Tal- Baramati, Dist - Pune, Maharashtra– 413115, IN
2 Department of Pharmaceutical Chemistry, Shivnagar Vidya Prasarak Mandal's College of Pharmacy, Malegaon (Bk), Tal- Baramati, Dist - Pune, Maharashtra – 413115, IN
3 Department of Pharmaceutical Chemistry, Shivnagar Vidya Prasarak Mandal's College of Pharmacy, Malegaon (Bk), Tal- Baramati, Dist -Pune, Maharashtra, IN
4 Department of Pharmacology, Shivnagar Vidya Prasarak Mandal's College of Pharmacy, Malegaon (Bk), Tal- Baramati, Dist -Pune, Maharashtra – 413115, IN
5 Department of Pharmaceutical Chemistry, Shivnagar Vidya Prasarak Mandal’s College of Pharmacy, Malegaon (Bk), Tal- Baramati, Dist - Pune, Maharashtra – 413115, IN

Abstract

A rapid dissolution method was developed for the evaluation of Roxithromycin tablets and the determination of Roxithromycin content was done by UV-spectrophotometer. The proposed method comprises the measurement absorbance of standard concentrations of Roxithromycin in the pH 6.0 phosphate buffer solution against wavelength maximum [max] of 205 nm. Beer's Law limits were obeyed in the concentration range of 1μg/ml - 10μg/ml. The linear regression coefficient was estimated to be 0.999 and the linear regression equation obtained was y=0.0954x-0.0014. The solutions were stable for more than 12 hours. The method has been extended for the determination of Roxithromycin content in tablets after the dissolution for 60 minutes at 50 rpm using USP Apparatus II [Paddle apparatus] under experimental conditions. The unknown concentration of Roxithromycin in the solution was estimated from the standard curve and it was found to be within the range of the labeled claim. The relative standard deviation of six replicate solutions was determined to be 0.55. No interference of excipient and coating material was found in this method. This method is economical, precise and accurate. Hence, this method can be employed for the routine evaluation of Roxithromycin tablets by dissolution and dissolution profile by using pH 6.0 phosphate buffer as a medium.

Keywords

Roxithromycin, Spectrophotometric, Validation, Dissolution.

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Pranali Gund ¹, Shrikrishna Baokar ², Santosh Undare ³

Affiliations
1 Department of Pharmaceutical Chemistry, Shivnagar Vidya Prasarak Mandal’s College of Pharmacy, Malegaon (Bk), Tal- Baramati, Dist - Pune, Maharashtra–413115, IN
2 Department of Pharmaceutical Chemistry, Shivnagar Vidya Prasarak Mandal’s College of Pharmacy, Malegaon (Bk), Tal- Baramati, Dist - Pune, Maharashtra, India – 413115, IN
3 P.G. Department of Chemistry, Marathwada Shikshan Prasarak Mandals, Balbhim Arts, Science and Commerce College, Beed, Dist- Beed, Maharashtra-431122., IN

Abstract

A simple, precise and accurate difference spectroscopic method has been developed for the estimation of Acyclovir in bulk and in pharmaceutical dosage form. The proposed method is based on the principle that Acyclovir can exhibit two different chemical forms in basic and acidic medium that differ in the absorption spectra in basic and acidic medium. Since the drug was freely soluble in distilled water, a stock solution (1 mg/mL) was prepared with distilled water. Further dilution was made by using 0.1 M sodium hydroxide and 0.1 M hydrochloric acid separately. The maxima and minima in the difference spectra of Acyclovir were at 256 nm. Difference in absorbance between these maxima and minima was calculated to find out the amplitude. This amplitude was plotted against concentration. Beer's law is valid in the concentration range of 1-5 μg/mL. As per ICH guidelines results of analysis were validated statistically and all the results were found satisfactory.

Keywords

Acyclovir, Difference Spectroscopic Method, Sodium Hydroxide, Hydrochloric Acid.

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